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Technical Briefs
Laboratory Developed Tests: Current State of Play FAQ
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Technical Briefs
Structured Dialogue: A Key to Efficient Regulatory Compliance in the EU
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White Papers
Shattering Barriers: Advancing Healthcare Equity by Enhancing Diversity in Clinical Trials for a Future of Inclusive Innovation
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RQM+ Live!
Live! #83 — Structured Dialogue: How to Engage with Notified Bodies
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Technical Briefs
Global Perspectives: Comparing Regulations for Point of Care Tests in the U.S. and EU
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Technical Briefs
AI/ML-Enabled Medical Devices: Recognition & Reliance in the UK
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RQM+ Live!
Live! #82 - MDR and IVDR Amendments: Strategies for Supply Interruption Compliance
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Technical Briefs
An Overview of Chemical Characterization of Medical Devices
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RQM+ Live!
Live! #81 - Advancing Health Equity with IVDs & Medical Devices
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Technical Briefs
Unbiased Outcomes: The Challenges of Equity in MedTech
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Technical Briefs
Impact of FDA's Final LDT Rule: Industry Concerns and Compliance
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Technical Briefs
Three for the Price of One: The Latest Amendments to the MDR & IVDR Have Arrived
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RQM+ Live!
Live! #80 - Beyond EtO: New EPA Regulations and Sterilization Alternatives
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Technical Briefs
The German DiGA Idea: Revolutionizing Health Care with Digital Health Applications
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White Papers
White Paper: The German DiGA (Digital Health Applications) Idea
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Technical Briefs
Future-Proofing Sterilization: Understanding EPA's New EtO Standards and What To Do Now
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Technical Briefs
Key Benefits of Chemical Characterization Laboratory Services
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Technical Briefs
Three Critical Aspects of Analytical Testing for Pharmaceuticals
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Webinars
Adapting to the New LDT Regulatory Reality: The Path to Compliance
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RQM+ Live!
Live! #79 - FDA's Wound Care Shakeup: Ensuring Your Products Make the Cut
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Technical Briefs
The Road to Remediation: Ensuring Quality, Safety, and Compliance in MedTech
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Webinars
We Need to Talk About Risk: The Critical Role of Communication in Risk Management
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Technical Briefs
FDA Proposed Rule: Impact on Wound Care Devices
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Webinars
Modernizing MedTech Research via Hybrid Study Approaches to Enhance Your Patient Recruitment
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Technical Briefs
Polymer Failure Analysis with Jordi Labs, an RQM+ Company
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RQM+ Live!
Live! #78 – Behind the Scenes with BSI Head of IVD Notified Body, Alex Laan
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Technical Briefs
New FDA Dataset Marks a Transformative Leap for Chemical Characterization
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Webinars
Aligning Your QMS with the FDA's QMSR Updates
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Technical Briefs
Nancy Morrison's Keys to Thriving in Regulatory Affairs: Lessons Learned from a 30+ Year Career
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Technical Briefs
Navigating PFAS Regulations: Lab Analysis for Medical Device Material Changes
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RQM+ Live!
Live! #77 – Get Ahead of the Crisis: How Your Quality System Can Prevent Negative Impacts on Customers, Patients, and Reputation
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Technical Briefs
Brought to You by the Letter M: Operational Considerations for Transitioning From the QSR to the QMSR
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Technical Briefs
What are Extractables and Leachables?
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Technical Briefs
8 Strategic Advantages of Outsourcing Audits
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Technical Briefs
Streamlining AE Reporting in PMCF Studies (FDA Perspective)
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White Papers
Are We Equipped to Handle a PFAS-Free Future?
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Technical Briefs
Classification for SARS-CoV-2: Adjusting to a Post-Pandemic Reality Under IVDR
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RQM+ Live!
Live! #76 – MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices
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Technical Briefs
Checklist for Navigating PFAS Phase-Out in MedTech
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Technical Briefs
Decoding MDCG 2023-7: New Clinical Evidence Pathways for Legacy and New Devices
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Technical Briefs
Enhancing Competitiveness in MedTech: Smart Strategies with Regulatory Intelligence
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White Papers
White paper: The Real Cost of Noncompliance: Leveraging IVDR for Long Term Savings
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RQM+ Live!
Live! #75 – Exiting PFAS: A Strategic Blueprint for Medical Device Manufacturers
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Technical Briefs
The Most Common Issues Affecting Biocompatibility Tests
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Technical Briefs
Unveiling MDCG 2023-7: Equivalence, Clinical Investigations and Data Access Under EU MDR
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Technical Briefs
Preparing for the Phase-Out of PFAS in MedTech Manufacturing
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Technical Briefs
Why You Should Verify Your Supplier's MedTech Materials
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RQM+ Live!
RQM+ Live! #74 — A New Era of LDT Oversight: Adapting to FDA Regulations
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Technical Briefs
Musical Chairs MDR-Style: Keep dancing even though the music has stopped.
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Technical Briefs
Enough Is Enough: Deciding When Your Safety Evaluation Is Complete
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RQM+ Live!
RQM+ Live! #73 — October Overview: Essential Insights from an Eventful Month in MedTech
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RQM+ Live!
RQM+ Live! #72 — EU MDR Timelines and Fine Lines: Unraveling Critical Transition Nuances to Gain Compliance
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RQM+ Live!
RQM+ Live! #71 — Material Matters: Navigating Risks and Strategies for Improving Medical Device Safety
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RQM+ Live!
RQM+ Live! #70 — IVDR Class D Devices: Advanced Strategies for Succeeding In a Dynamic Regulatory Environment
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Technical Briefs
Don't Get Caught Off Guard: How to Meet the EU's 2024 MDR Deadlines
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Technical Briefs
5 Tips for IVDR Certification of Companion Diagnostics
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RQM+ Live!
RQM+ Live! #69 — Insider Perspectives: Mastering EU Compliance with BSI's Richard Holborow and RQM+'s Amie Smirthwaite
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Technical Briefs
Mastering the Transition: 5 Essential Tips for EU MDR Compliance
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Technical Briefs
Breaking New Ground: Introducing the Transitional Coverage for Emerging Technologies (TCET) Pathway
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RQM+ Live!
RQM+ Live! #68 — Pre-Submission to Preeminence: Showcasing FDA's Latest Pre-Sub Guidance and Uncovering PCCP Best Practices
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RQM+ Live!
RQM+ Live! #67 — Beyond Indications: Managing Off-Label Use for Safety and Compliance
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RQM+ Live!
RQM+ Live! #66 — Pragmatic and Compliant Approaches to Clinical Evidence
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Webinars
Practical Points in Creating Clinical Evidence for AI SaMD Medical Devices
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RQM+ Live!
RQM+ Live! #65 — How AI is Revolutionizing MedTech: Current and Future Applications
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RQM+ Live!
RQM+ Live! #64 — The Evolving Biocompatibility Landscape: Staying Ahead of Regulatory Requirements
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RQM+ Live!
RQM+ Live! #63 — Start 2023 Right: Smart and Savvy Tips from Former Regulators and Notified Bodies
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Technical Briefs
Summary of FDA Regulatory Changes for Digital Health Devices in Q3 2022
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Case Studies
Case Study: RQM+ Partners With Global IVD Manufacturer to Remediate Over 150 IVDR Technical Files
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Technical Briefs
Medical Device Software: Top Regulatory Submission/File Deficiencies and Requests for Additional Info From Both FDA and Notified Bodies
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Technical Briefs
European Union Expert Panel's Review of a Novel Neurostimulation Device
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Webinars
Common FDA and Notified Body Software Deficiencies and How to Avoid Them
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Technical Briefs
How the FDA Encourages Innovation in Pediatric Medical Devices and Best Practices for Submissions
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RQM+ Live!
RQM+ Live! #62 — Standards and State of the Art (SOTA)
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Technical Briefs
Review of RQM+ Findings in Mock Audits and Notified Body Submissions
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RQM+ Live!
RQM+ Live! #61 — Medical Device Software: Top Deficiencies and Requests for Additional Info from FDA and Notified Bodies
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Technical Briefs
Lessons Learned From Using the FDA Customer Collaboration Portal (CCP) for eCopy and eSTAR
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White Papers
Compliance Strategy
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RQM+ Live!
RQM+ Live! #60 — RAPS Convergence Takeaways: RQM+ event speakers share their biggest surprises and learnings
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Technical Briefs
Are in Silico Trials a Fit for the Medical Device Industry?
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Technical Briefs
How to Submit FDA CDRH Submissions Online
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Technical Briefs
Impact of a High-Quality IVDR Notified Body Application
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RQM+ Live!
RQM+ Live! #59 — Clinical Evidence vs. Clinical Performance – A Deep Dive into MDCG 2022-2 and Notified Body Expectations
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RQM+ Live!
RQM+ Live! #58 —Regulatory Landscape of Companion Diagnostics (CDx) in the EU
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RQM+ Live!
RQM+ Live! #57 — FDA Appeals Process
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Technical Briefs
US FDA Update: Is it a Device? After the Fact Design History Files
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RQM+ Live!
RQM+ Live! #56 — IVDR: A Notified Body Perspective (featuring Marta Carnielli of TÜV SÜD)
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Technical Briefs
Impact of FDA Adoption of ISO 13485
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Technical Briefs
3 Tips for Efficiently Preparing Your FDA eSTAR Submission
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RQM+ Live!
RQM+ Live! #55 — Is your labeling thrice as big as your device yet?
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Technical Briefs
Overcoming the Most Common Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report Challenges
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Webinars
EU IVDR: Intriguing Insights, Recommended Actions, and a Look Towards the Future
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Technical Briefs
How Your Medical Director Can Help You Scope SOTA Properly: A Physician's Perspective
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RQM+ Live!
RQM+ Live! #54 — Implications of FDA Adopting ISO 13485 and How to Prepare
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Technical Briefs
IVDR State of the Art (SOTA)
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Webinars
An Intuitive Approach to Quantifying the Benefit-Risk Ratio
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RQM+ Live!
RQM+ Live! #53 — Part 2: PSURs – Ready, Set, Go!
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Technical Briefs
A Quantitative Approach to Benefit-Risk Determination
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Technical Briefs
Risk Management Challenges with IVDR Compliance - This May Be Your Biggest Obstacle
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RQM+ Live!
RQM+ Live! #52 — Part 2: What’s new in the world of biocompatibility for medical devices?
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White Papers
Benefit-Risk Determination: A Quantitative Approach
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RQM+ Live!
RQM+ Live! #51 — Leveraging your medical directors and clinicians for successful regulatory submissions
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Technical Briefs
What You Need to Know About Significant Changes Under IVDR
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RQM+ Live!
RQM+ Live! #50 — IVDR Notified Body Application Process
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Technical Briefs
Using Chemical Characterization to Achieve Biological Equivalence
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White Papers
Strategy for Leveraging Chemical Characterization & Toxicological Assessments Towards Biological Equivalence
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RQM+ Live!
RQM+ Live! #49 — PSURs – Ready, Set, Go!
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PSURs – Ready, Set, Go!
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Webinars
Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR
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Technical Briefs
How to Prepare for COVID-19 EUA or Enforcement Policy Expiration
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Technical Briefs
Europe: 2021 Year-End Review & Looking Ahead to 2022
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Technical Briefs
Just Released: MDCG Guidance 2022-3 Verification of Manufactured Class D IVDs by Notified Bodies
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RQM+ Live!
RQM+ Live! #48 — Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
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Part 2: Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
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Technical Briefs
Software as a Medical Device
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Technical Briefs
EU Update: Expert Panel Views for SARS-CoV-2 Devices
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Technical Briefs
In case you missed it: 2021 Expert Content from the RQM+ Knowledge Center
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RQM+ Live!
RQM+ Live! #47 — Have we been looking at EU MDR equivalence requirements all wrong?
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Have we been looking at EU MDR equivalence requirements all wrong?
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Technical Briefs
FDA CDRH: What will they do in 2022?
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Technical Briefs
Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR
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Technical Briefs
RQM+ Executive Video Briefing: IVDR New Transition Timelines
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RQM+ Live!
RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA Submissions
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Year-end Review and 2022 Outlook on FDA Submissions
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Technical Briefs
MDR and IVDR Mock Technical Assessments and Design Examinations
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Technical Briefs
FDA CDRH 2021: A Year in Review
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Technical Briefs
The IVDR Performance Evaluation Report
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Technical Briefs
EU MDR Article 61 and equivalence – is there a new way forward?
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Technical Briefs
UK Approved Bodies: on your UKCA mark, get set, go!
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RQM+ Live!
RQM+ Live! #45 — What’s new in the world of biocompatibility for medical devices?
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Technical Briefs
Clinical Evidence Requirements Under IVDR
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What’s new in the world of biocompatibility for medical devices?
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White Papers
Performance Data and EU IVDR
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Technical Briefs
What do we know so far about post-Brexit medical device regulation?
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Technical Briefs
Canada Regulations News for Medical Devices and IVDs
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RQM+ Live!
RQM+ Live! #44 — Success Stories of PMCF Surveys: Strategy and Execution
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Success Stories of PMCF Surveys: Strategy and Execution
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Technical Briefs
Impact of of MDCG 2021-24 on the Classification of Spinal Implants
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Technical Briefs
Is Your Medical Device a Well-Established Technology (WET)?
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Webinars
Overcoming Your Challenges and Streamlining the SSP and SSCP
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RQM+ Live!
RQM+ Live! #43 — Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24
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Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24
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Technical Briefs
Overcoming Challenges and Streamlining Your SSCPs and SSPs
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White Papers
10 Steps to Prepare for UK Conformity Assessment
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Technical Briefs
What Are Clinical Benefits and How Do You Evaluate Them in Your CER?
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Technical Briefs
Facts & FAQs: European Commission Proposal for Amendment of the IVDR (EU) 2017/746
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RQM+ Live!
#41 — Best Practices for Optimizing PMCF and Avoiding NB Findings
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Best Practices for Optimizing PMCF and Avoiding NB Findings
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Technical Briefs
Integrating Post-Market Surveillance Into Your QMS
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Technical Briefs
Post-Market Surveillance: A Concise Overview of Requirements
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RQM+ Live!
#40 — When should we throw the least burdensome flag or appeal an FDA decision?
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When should we throw the least burdensome flag or appeal an FDA decision?
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Technical Briefs
Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document
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Technical Briefs
EU Update: SARS-CoV-2 In Vitro Diagnostic Medical Device Performance Evaluation MDCG Guidance Published
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Technical Briefs
RQM+ MDR Clinical Evaluation Roadmap: An Interview with Dr. Jai Kutty
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Technical Briefs
8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9
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RQM+ Live!
#39 — Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
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Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
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Interactive Tools
MDR Filtering Tool
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White Papers
Biological Equivalence Whitepaper
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Webinars
Webinar Recording: Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance
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Best Practices in Site Transfer (or Consolidation)
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RQM+ Live!
#38 — Best Practices in Site Transfer (or Consolidation)
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Interactive Tools
IVDR Filtering Tool
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Technical Briefs
An Overview of Summary of Safety and Performance (SSP) Under IVDR
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RQM+ Live!
#37 — U.S. FDA Pathways for Innovative Devices
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U.S. FDA Pathways for Innovative Devices
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Technical Briefs
RQM+ Quick Guide to Medical Device Recall Management
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Webinars
Event Recording — FDA Submissions in 2021: How's it going?
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RQM+ Live!
#36 — Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2!
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Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2!
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Technical Briefs
How to Prepare a Design History File for FDA Inspection
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Technical Briefs
A Comparison of IVDR to FDA IVD Regulatory Submission Requirements
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RQM+ Live!
#35 — Preparing for PSURs
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Preparing for PSURs
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Technical Briefs
Optimizing your Technical Documentation to reduce NB review time and questions (Medical Devices and IVDs)
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Webinars
RAPS + RQM+ Webcast: PMCF User Feedback Surveys
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Technical Briefs
How to Obtain CE Marking Under the MDR
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White Papers
PMCF Under EU MDR Whitepaper
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RQM+ Live!
#34 - Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)
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Interactive Tools
IVDR Knowledge Test
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Interactive Tools
IVDR Readiness Assessment
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Interactive Tools
MDR PMCF Checklist
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Technical Briefs
Everything You Need to Know About the Medical Device Single Audit Program (MDSAP)
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Technical Briefs
How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR
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Technical Briefs
Top 4 Findings from Notified Body Technical Documentation Audits Under EU MDR
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Technical Briefs
How to Obtain CE Marking Under the IVDR
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Technical Briefs
Quick Guide to Medical Device Standards: ISO Standards and Beyond
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Technical Briefs
ISO 14971: 2019: 3 Key Changes from ISO 14971: 2007
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Webinars
PMCF User Feedback Surveys
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Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions (Devices & IVDs)
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#Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions
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RQM+ Live!
#33 - Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions
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Webinars
MassMEDIC Mid-Year FDA Update 2021 — FDA Submissions in 2021: How's it going?
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Video FAQs
Will there be a continued impact of COVID on FDA resources and submission timelines?
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Video FAQs
What are the common issues with 510(k) submissions that are easy to avoid?
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Video FAQs
What are some tips from RQM+ former FDA CDRH and SMEs on good letter to file documentation?
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Video FAQs
What are some best practices for defining your intended purpose statement under IVDR?
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Video FAQs
As a regulatory director, what IVDR transition milestones would you set for the end of 2020?
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Video FAQs
How do you determine what is considered sufficient clinical evidence for an IVD to satisfy NB?
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Video FAQs
Why should I build a quality system backwards?
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Video FAQs
Why do regulatory compliance experts need to be involved in the due diligence process when considering an acquisition of a medical device firm?
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Video FAQs
What should a Merger and Acquisition due diligence regulatory compliance assessment include?
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Video FAQs
What areas tend to be more problematic, or burdensome to overcome, for the purchasing organization?
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Video FAQs
Is it preferable to meet the standards FDA lists as consensus standards over meeting the latest version of that standard?
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Video FAQs
What sample size is needed in my Performance Qualification (PQ)?
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Video FAQs
How big does a Performance Qualification (PQ) run have to be?
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Video FAQs
Why can’t I use ANSI Z1.4 to find my validation sample size?
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Video FAQs
Can we use PMCF to fill current clinical evidence gaps?
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Video FAQs
What are examples of inadequate PMCF data resulting in audit findings in MDD or MDR audits?
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Video FAQs
The integration of clinical, regulatory, risk management and post market surveillance is a difficult and confusing task.
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Video FAQs
Do all residual risks identified need to be listed in your IFU and SSCP?
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Video FAQs
Who decides what residual risks should be listed and could the NB push for a specific risk?
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Video FAQs
Under what circumstances are PMCF surveys the solution?
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Video FAQs
What was intent behind the MDCG guidance for Biological Equivalence and how did it help?
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Video FAQs
What have you been hearing from Notified Bodies (SSCPs)?
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Video FAQs
Relative to biological equivalence requirements, what are the differences from MDD to MDR?
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Video FAQs
There are 3 rounds of questions, but if the NB brings in a new expert during the review (clinical, for example), will that additional reviewer have his/her own 3 rounds of questions?
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Video FAQs
What are the timelines looking like for an MDR review?
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Video FAQs
What should we do for the development plan requirement for a legacy device?
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Video FAQs
What are the regulatory requirements for the intended purpose statement and why are companies struggling with compliance?
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Video FAQs
As a manufacturer, why should we bother to figure out how the MDR and IVDR will be interpreted by the NB's?
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Video FAQs
Can you have a CER with multiple products, some of which are under the MDR and some that will remain under the MDD until a later date?
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Video FAQs
How do you make a decision on "good enough" and how do you align with the regulators on this decision?
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Video FAQs
What are some best practices for DHF remediation efforts?
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Video FAQs
How to receiving an RTA (refuse to accept) from FDA on your 510(k) submission?
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RQM+ Live!
#32 - What if I'm not ready for EU MDR on May 26, 2021?
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What if I'm not ready for EU MDR on May 26, 2021?
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White Papers
Common Technical Documentation Deficiencies
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RQM+ Live!
#31 - Biological Equivalence Demystified
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Biological Equivalence Demystified
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RQM+ Live!
#30 - IVD Intended Purpose Statements – Defining for Success
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IVD Intended Purpose Statements – Defining for Success
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RQM+ Live!
#29 - The surprising true cost of submitting non-compliant technical documentation to notified bodies
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The surprising true cost of submitting non-compliant technical documentation to notified bodies
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Technical Briefs
MDCG 2020-16 Classification Guidance for IVDs
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RQM+ Live!
#28 - Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR
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Overcoming Challenges with Integrating PMS, CERs/PERs and Risk Management under EU MDR and IVDR
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RQM+ Live!
#27 - 2021 Outlook on FDA Submissions
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2021 Outlook on FDA Submissions
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Webinars
Best Practices in Scientific Database Searching
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RQM+ Live!
#26 - What is the Biggest EU MDR or IVDR Question You Need to be Answered?
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What is the Biggest EU MDR or IVDR Question You Need to be Answered?
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Unknown Identification
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Solution Viscosity
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Intrinsic Viscosity
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Thermomechanical Analysis
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Thermal Gravimetric Analysis
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Modulated Differential Scanning Calorimetry
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Differential Scanning Calorimetry
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RQM+ Live!
#25 - Is ISO 14971:2019 required under MDR/IVDR?
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Is ISO 14971:2019 required under MDR/IVDR?
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Differential Scanning Calorimetry Oxidative Induction Time (DSC-OIT)
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Thermal Analysis
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Wearability Analysis/Taber Abrasion Test
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Ultra Violet Spectroscopy
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RQM+ Live!
#24 - Generating Sufficient Clinical Evidence for IVDs
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Generating Sufficient Clinical Evidence for IVDs
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Nuclear Magnetic Resonance Spectroscopy
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FTIR-Microscopy
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Fourier Transform Infrared Spectroscopy
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Electron Spectroscopy for Chemical Analysis
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RQM+ Live!
#23 - Make real world evidence work for you: How to leverage real world data in the US and EU
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Make real world evidence work for you: How to leverage real world data in the US and EU
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Spectroscopy
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Specific Gravity
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Solid Phase Extraction
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Reverse Phase Chromatography
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Tensile Strength Testing
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RQM+ Live!
#22 - Summary of Safety and Clinical Performance
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Summary of Safety and Clinical Performance
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Rotational Rheometry
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Surface Area and Porosimetry Measurements
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Melt Flow Rate
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Impact Resistance (Impact)
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Impact Resistance Test
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RQM+ Live!
#21 - Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys
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Avoid Audit Findings! Collecting Relevant Data for PMCF Surveys
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Flexural Test
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Dynamic Mechanical Analysis
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Combustion (Ashing)
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Capillary Rheometry
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Ashing
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Commercializing Medical Devices in a Post-Brexit World
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Physical Testing
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Porosimetry Analysis by Gas Adsorption
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Porosimetry Analysis by Mercury Intrusion
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Webinars
Program Management for IVDR and EU MDR
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Webinars
Strategies for Interpreting the IVDR for Successful Implementation
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Physical Testing
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RQM+ Live!
#19 - The most popular PMCF and PMPF questions from our clients
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The most popular PMCF and PMPF questions from our clients
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Particle Size and Shape Analysis by Light Microscopy
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Webinars
Integrating Risk and Compliant Management
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Laser Light Scattering Particle Size Analysis
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RQM+ Live!
#17 - Periodic Safety Update Report: How do you write it without guidance?
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Electrozone Sensing Particle Size Analysis
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Dynamic Light Scattering Particle Size Analysis
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Periodic Safety Update Report: How do you write it without guidance?
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Dynamic Light Scattering
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Normal Phase Chromatography
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Twister Stir-bar Sorptive Extraction w/ Thermal Desorption GCMS
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Time of Flight - Secondary Ion Mass Spectrometry
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Quadrupole Time of Flight Liquid Chromatography Mass Spectrometry
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Creating Performance Evaluation Plans and Reports under the IVDR
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Pyrolysis Mass Spectrometry
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Triple Quadrupole Liquid Chromatography Mass Spectrometry
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Liquid Chromatography Mass Spectroscopy (Quantitative)
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Liquid Chromatography Mass Spectrometry (Qualitative)
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Liquid Chromatography Mass Spectroscopy
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RQM+ Live!
#15 - When to use the FDA Q-Submission (Pre-Sub) Program
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When to use the FDA Q-Submission (Pre-Sub) Program
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Inductively Coupled Plasma Mass Spectrometry
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Low Energy Electron Ionization (EI) GCMS
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Quadrupole Time of Flight Gas Chromatography Mass Spectrometry
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Headspace Gas Chromatography Mass Spectrometry
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Webinars
Economic Operators: Addressing the EU MDR and IVDR requirements head-on
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Gas Chromatography Mass Spectrometry (Qualitative)
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Evolved Gas Analysis
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RQM+ Live!
#14 - Is your device a Well-Established Technology (WET) under EU MDR?
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Is your device a Well-Established Technology (WET) under EU MDR?
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White Papers
The New EU MDR: Practical Implications for Manufacturers
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Gas Chromatography Mass Spectrometry
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Gas Chromatography – Flame Ionization Detector
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Desorption Mass Spectrometry
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Dynamic Headspace Gas Chromatography Mass Spectrometry
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Mass Spectrometry
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Is this software application a medical device?
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Webinars
PMCF Plans: How to create detailed, compliant, and business-balanced PMCF plans
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Webinars
Strategies for Successful PMCF Planning and Execution
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Transmission Light Microscopy
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Molecular Weight
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Transmission Electron Microscopy
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Stereo Microscopy
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Scanning Electron Microscopy
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Polarized Light Microscopy
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RQM+ Live!
#12 - Tips and Tricks for a Smooth 510(k) Process
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Tips and Tricks for a Smooth 510(k) Process
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Optical Microscopy
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Webinars
Developing an FDA Regulatory Strategy: Part 2 - A Definitive Guide for Entering the US Market
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Atomic Force Microscopy
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RQM+ Live!
#11 - I don't have clinical data for my device. What are my options for fulfilling the sufficient clinical evidence requirements under EU MDR?
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I don't have clinical data for my device. What are my options for fulfilling the sufficient clinical evidence requirements under EU MDR?
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Microscopy
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Method Development
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Limit of Detection Determination
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RQM+ Live!
#10 - Transition to IVDR: How far along should we be?
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Transition to IVDR: How far along should we be?
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Ion Exchange Chromatography
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Reverse Phase/ Normal Phase HPLC
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RQM+ Live!
#9 - Experiences with the FDA 3rd Party 510(k) Review Program
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Experiences with the FDA 3rd Party 510(k) Review Program
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Preparative HPLC
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High Performance Liquid Chromatography - Qualitative
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HPLC-A
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FDA Trends: Inspections and Submissions
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Fraction Collection
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High Pressure Liquid Chromatography
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RQM+ Live!
#7 - Getting Legacy Device Risk Files Ready for EU MDR / ISO 14971:2019
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Getting Legacy Device Risk Files Ready for EU MDR / ISO 14971:2019
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Hydrophilic Interaction Liquid Chromatography
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Webinars
FDA Emergency Use Authorization (EUA) and EU MDR Article 59
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Gradient Polymeric Elution Chromatography
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RQM+ Live!
#6 - PMCF Process in Action: Best Practices for MDR Compliance
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PMCF Process in Action: Best Practices for MDR Compliance
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2d Chromatography
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High Temperature Triple Detection Gel Permeation Chromatography
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RQM+ Live!
#5 - Chatting with Former FDA and Notified Body Representatives
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Chatting with Former FDA and Notified Body Representatives
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Temperature Rising Elutriation Fractionation
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Thermal Gradient Interaction Chromatography
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RQM+ Live!
#4 - Best Practices for Easing the Burden of a Medical Device Remediation Program
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Gel Permeation Chromatography Standardized
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Gel Permeation Chromatography – Quantitative Analysis
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Webinars
Case Studies of MDD and MDR Audit Findings... and Lessons Learned
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Recent MDD and MDR Audit Findings: What are we seeing?
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High Temperature Gel Permeation Chromatography
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Ultra High Resolution Gel Permeation Chromatography
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RQM+ Live!
#2 - Use of FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for COVID-19 Public Health Emergency
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Use of FDA Emergency Use Authorization (EUA) process and EU MDR Article 59 to release devices needed for COVID-19 Public Health Emergency
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What is Dynamic Mechanical Analysis Used For?
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Gel Permeation Chromatography – Tetra Detection
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Gel Permeation Chromatography Single Wavelength Infrared Spectroscopy
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Gel Permeation Chromatography Fourier Transform Infrared Spectroscopy
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Moving medical device manufacturing out of China
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Flow Injection Polymer Analysis
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Webinars
PMS Requirements for EU MDR: Implementation Challenges and Solutions
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Webinars
PMS Requirements of the EU MDR: Implementation Challenges and Solutions
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Webinars
Structuring PERS Under IVDR: How to gather and present data, conduct literature searches, and more.
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Crystallization Analysis Fractionation (CRYSTAF)
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Crystallization Elution Fractionation (CEF)
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Asymmetric Flow Field Flow Fractionation
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Gel Permeation Chromatography
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Webinars
EU MDR Audits: Preparing, Managing, and Responding to Nonconformances
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Gas Chromatography Mass Spectrometry (Quantitative)
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X-ray Fluorescence
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X-Ray Diffraction
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X-ray Photoelectron Spectroscopy or Electron Spectroscopy for Chemical Analysis
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Scanning Electron Microscopy
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Proton Induced X-ray Emission
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Neutron Activation Analysis
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Inductively Coupled Plasma Optical Emission Spectrometry
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CHNO by Combustion
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White Papers
Economic Operators: Whose Problem Is It Anyway?
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Elemental Analysis
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Dissolution Study
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Cryogrinding
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Coefficient of Thermal Expansion
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Working Principles and Applications of Scanning Electron Microscopy
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Preparative HPLC
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Liquid Chromatography
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Gel Permeation Chromatography
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Total Organic Carbon
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Titrimetry
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Soxhlet Extraction
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pH Determination
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Webinars
Developing an FDA Regulatory Strategy: Part 1 - A Definitive Guide for Entering the US Market
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Karl Fischer Titration
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Gravimetric Analysis
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510(k): What is a Premarket Notification?
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Crosslink Density Determination
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Bench Chemistry
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Webinars
Solving the EU MDR Labeling Puzzle
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What GMP Means in Pharma
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How to Conduct Molecular Weight Analysis
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What is Polymer Molecular Weight?
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What is Elemental Analysis Used For?
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Webinars
EU MDR for Combination Products: The rules have changed with Article 117 and more companies will require notified body involvement.
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How to Choose a GPC Column
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Analyzing Solar Cells via X-ray Diffraction
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Protein Characterization, Identification & Purification
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The Working Principles of Gel Permeation Chromatography
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Premarket Notification: 510(k) FDA
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Polymer Testing: Polyethylene and End of Life Management
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Using Transmission Electron Microscopy to Analyze Engineering Materials
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What is Thermal Gravimetric Analysis?
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Typical Molecular Weights of Common Polymers
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What is Transmission Electron Microscopy?
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Polymer Failure Analysis with RQM+ Lab Services
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A Beginner’s Guide to Dynamic Mechanical Analysis
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Food Toxicology: Testing Food Contact Materials
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White Papers
The New EU IVDR: Practical Implications for Manufacturers
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Measuring Polymer Exemptions with Gel Permeation Chromatography
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Good Manufacturing Practice in the Medical Device Industry
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Overcoming Uncertainty in E&L Testing
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Polyethylene (PE) High Temp GPC Separation Example
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Pharmaceutical Lab Testing: APIs, Excipients, and Contact Materials
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E&L: Key Principles of Extractables & Leachables Analysis
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Titrimetry in Wine Analysis
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Particulates and Residues in Medical Devices
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E&L Testing: Methods of Chemical Characterization
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Exploring the Importance of Polymer Analysis
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Contamination Detection: Particulates and Residue Analysis with RQM+ Lab Services
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What is ISO 10993 Used for?
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Carrying Out Particle Analysis Using DLS
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UV-VIS Absorbance and Protein Characteristics
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An Overview of Toxicological Risk Assessments
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How to Develop a Biological Evaluation Plan
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Engineering Plastics via Gel Permeation Chromatography
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Preparing for New Regulations of Elemental Impurities in Drugs
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What is the Karl Fischer Titration Method?
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7 Methods of Assessing Protein Purity
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Biological Endpoint Testing in Biocompatibility Evaluations
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Chemical Characterization Testing of Medical Devices
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Common Mistakes in Extractables and Leachables Analysis
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Determination of Protein Molecular Weight
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Identifying Particulates and Residue in Pharmaceuticals
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Christmas Tree: Artificial or Real
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What Extractable and Leachable Compounds are Found in Syringes?
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Product Deformulation: Reverse Engineering with RQM+ Lab Services
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Applications of Thermal Gravimetric Analysis
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E&L For Bis(2,4-di-tert-butylphenyl)-phosphate (bDtBPP)
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Product Deformulation: A Step-by-Step Guide to Reverse Engineering
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Common Causes of Polymer Failure
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Contaminant Analysis: How to Interpret Particulate Matter
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New Trends in Analytical Chemistry – The Corona Charged Aerosol Detector (CAD)
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Molecular Weight Determination of Pharmaceuticals with Novel GPC
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The Basics of Polymer Analysis: Techniques & Solutions
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Risk Assessment Strategies in Extractables and Leachables
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5 Key Elements of GMP in the Food Industry
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Molecular Weight Analysis: How to Measure MW?
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A Systematic Study of Response Factor Variation for Extractables and Leachables
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What are Extractables and Leachables?
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How We Conduct ISO 10993 Medical Devices Evaluations
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ICH Q1B: Photostability Testing of New Drug Substances and Products
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Titrimetry: A Brief Overview
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The Working Principles of Dynamic Light Scattering
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