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“RQM+ is always the first resource I think of when assistance is needed. In addition I cannot state how grateful I am for your organizations thought leadership and resources/content. It’s best in class!”
In 2021, we launched the RQM+ Knowledge Center as your one-stop-shop to access a filterable library of content brought to you by our expert team's unrivaled collective knowledge.
Below is a recap of some of our content produced throughout 2021. You can always find each of these resources as well as all of the content we've produced so far in 2022 in our Knowledge Center. Be sure to subscribe to our blog to receive timely industry news, technical briefs, and expert content straight to your inbox.
Please note: The content listed below was created prior to the announcement of the extension to the IVDR transition period. Check out the RQM+ Executive Video Briefing: IVDR New Transition Timelines for a more recent review of the revised IVDR timeline.
RQM+ Live!
A biweekly and interactive live show featuring expert panelists discussing timely topics, challenges, and solutions in the medical device and diagnostics industries. The panelists answer audience questions and every episode is added to our Device Advice podcast too.
- #45 What’s new in the world of biocompatibility for medical devices?
- #44 Success Stories of PMCF Surveys: Strategy and Execution
- #43 Spinal Implantable Device Classification Changes Resulting from MDCG 2021-24
- #42 Unearthing IVDR with Former Notified Body Leader, Carlos Galamba
- #41 Best Practices for Optimizing PMCF and Avoiding NB Findings
- #40 When should we throw the least burdensome flag or appeal an FDA decision?
- #39 Sustaining EU MDR and IVDR certification in the post-market phase - What will it take?
- #38 Best Practices in Site Transfer (or Consolidation)
- #37 U.S. FDA Pathways for Innovative Devices
- #36 Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 2
- #35 Preparing for PSURs
- #34 Optimizing Technical Documentation to Reduce Notified Body Review Time and Questions
- #33 Types of EU MDR Clinical Evidence Gaps and Best Practice Solutions - Part 1
- #32 What if I'm not ready for EU MDR on May 26, 2021?
- #31 Biological Equivalence Demystified
- #30 IVD Intended Purpose Statements – Defining for Success
- #29 The surprising true cost of submitting non-compliant technical documentation to notified bodies
- #28 Overcoming Challenges with Integrating PMS, CERs/PERs & Risk Management under EU MDR & IVDR
- #27 2021 Outlook on FDA Submissions
- #26 What is the Biggest EU MDR or IVDR Question You Need to be Answered?
Webinars
RQM+ webinars provide deep-dives by our subject matter experts into your industry's most relevant topics. Upcoming webinars can be found in our Knowledge Center as well as our events page.
- Overcoming Your Challenges and Streamlining the SSP and SSCP
- Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance
- PMCF User Feedback Surveys
- MassMEDIC Mid-Year FDA Update 2021 — FDA Submissions in 2021: How's it going?
- Best Practices for Scientific Database Searching
Technical Briefs
Stay informed with the latest news, updates, and what you need to know in your industry by signing up to receive timely technical briefs from the RQM+ blog.
- The IVDR Performance Evaluation Report
- EU MDR Article 61 and equivalence – is there a new way forward?
- UK Approved Bodies: on your UKCA mark, get set, go!
- Clinical Evidence Requirements Under IVDR
- What do we know so far about post-Brexit medical device regulation?
- Canada Regulations News for Medical Devices and IVDs
- Impact of of MDCG 2021-24 on the Classification of Spinal Implants
- Is Your Medical Device a Well-Established Technology (WET)?
- Overcoming Challenges and Streamlining Your SSCPs and SSPs
- What Are Clinical Benefits and How Do You Evaluate Them in Your CER?
- Facts & FAQs: European Commission Proposal for Amendment of the IVDR (EU) 2017/746
- Integrating Post-Market Surveillance Into Your QMS
- Post-Market Surveillance: A Concise Overview of Requirements
- Top 10 Tips on How to Write a PMS Report and PSUR Without an Official Guidance Document
- EU Update: SARS-CoV-2 In Vitro Diagnostic Medical Device Performance Evaluation MDCG Guidance Published
- RQM+ MDR Clinical Evaluation Roadmap: An Interview with Dr. Jai Kutty
- 8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9
- RQM+ Case Study: Effective Managed Outsourcing for EU MDR
- An Overview of Summary of Safety and Performance (SSP) Under IVDR
- Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance
- Q&A: PMCF User Feedback Surveys
- Quick Guide to Medical Device Recall Management
- How to Prepare a Design History File for FDA Inspection
- A Comparison of IVDR to FDA IVD Regulatory Submission Requirements
- The EU MDR Date of Application Has Arrived!
- Optimizing your Technical Documentation to reduce NB review time and questions
- How to Obtain CE Marking Under the MDR
- Everything You Need to Know About the Medical Device Single Audit Program (MDSAP)
- How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR
- Top 4 Findings from Notified Body Technical Documentation Audits Under EU MDR
- How to Obtain CE Marking Under the IVDR
- Quick Guide to Medical Device Standards: ISO Standards and Beyond
- ISO 14971: 2019: 3 Key Changes from ISO 14971: 2007
- MDCG 2020-16 Classification Guidance for IVDs
- New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices
White Papers & Tools
Our white papers and tools are crafted by our experts to provide the information you need to stay informed.
- Performance Data and EU IVDR
- Brexit Guide: 10 Steps to Prepare for UK Conformity Assessment
- Biological Equivalence & The EU MDR
- PMCF Under MDR: Three Key Stages - Three Common Pitfalls
- MDR Filtering Tool
- IVDR Filtering Tool
- IVDR Knowledge Test
- EU IVDR Readiness Assessment
- MDR PMCF Planning Checklist
And we're just getting started
We love bringing you access to relevant content in our new RQM+ Knowledge Center and we have already added much more since the beginning of this year. Check out all the newly added expert resources and be sure to bookmark the page - we are adding new content weekly!
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