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IVDR

Join the RQM+ IVDR Session During RAPS Euro Convergence 2021

We are excited to host a panel discussion during next week's virtual RAPS Euro Convergence 2021! Join our expert panel for our session on IVDR Implementation Best Practices and Challenges. See the schedule here and find more details on our session below.
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medical device single audit program

Everything You Need to Know About the Medical Device Single Audit Program (MDSAP)

Maintaining regulatory and quality compliance across multiple markets is challenging. In addition to meeting stringent regulatory requirements, manufacturers must also submit to regular quality system audits. When operating in multiple markets, this often means a busy audit schedule that can distract from daily operations.
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iso standards for medical devices

Quick Guide to Medical Device Standards: ISO Standards and Beyond

In the regulatory world, standards are essentially recommended processes that have been developed by subject matter experts with the aim of describing the best possible way to meet an end goal. For example, quality management standards are designed to improve efficiencies and avoid product failures.
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iso 14971

ISO 14971: 2019: 3 Key Changes from ISO 14971: 2007

As the underlying risk management process for medical devices, the ISO 14971 standard is a critical component of regulatory and quality compliance. When new versions are released and harmonized, it’s up to manufacturers to learn about the changes to update systems accordingly. However, there is often a gap between the time a new version is released and when regulatory organizations require compliance.
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PSUR periodic safety update report

How to Create a Compliant Periodic Safety Update Report (PSUR) Under EU MDR and EU IVDR

The requirement for a periodic safety update report (PSUR) or post-market surveillance report (PMSR) is new under EU MDR and EU IVDR. MDD and IVDD had post-market requirements, but the MDR and IVDR requirements are more formal, and for most classes, these reports must be updated and submitted to notified bodies (NBs) on an annual or biennial basis. 
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regulatory submissions

Top 4 Findings from Notified Body Technical Documentation Audits Under EU MDR

As we complete regulatory submissions under MDR, we continue to learn from notified body feedback and audit findings. These lessons learned are captured and disseminated throughout the RQM+ team to build our unrivaled collective knowledge, but we also believe in sharing this valuable information with the industry. Here is what we have learned so far from notified body technical documentation audits under MDR.
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ivdr CE marking

How to Obtain CE Marking Under the IVDR

CE marking is the system used in the EU to indicate that products meet the region’s safety, health, and environmental protection requirements. Products labeled with the CE marking can be freely traded in the European Economic Area without restrictions.
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SSCP Requirements

8 Lessons Learned After Writing the Summary of Safety and Clinical Performance (SSCP) using MDCG 2019-9

EU MDR 2017/745 includes a requirement to write a summary of safety and clinical performance (SSCP) for implantable and Class III devices. Although this is still a relatively new requirement, RQM+ has already gained valuable experience preparing SSCPs on behalf of our clients. If you’re starting the process of creating your SSCPs, this post covers the basics and some lessons learned from our own experience.
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News

MDCG 2020-16 Classification Guidance for IVDs

February 16, 2021 - RQM+ experts summarize the MDCG guidance from November 2020, Guidance on Classification Rules for the in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746, to aid IVD industry stakeholders in understanding, planning, and executing compliance to the IVDR by May 2022. The examples in the blogpost are not intended to be exhaustive of all scenarios of applicability.
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News

Dr. Jaishankar Kutty Joins RQM+

February 1, 2021 - RQM+ welcomes Dr. Jai Kutty.
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News

New Guidance: FDA Safer Technologies Program (STeP) for Medical Devices

January 21, 2021 - U.S. Food & Drug Administration (FDA) released the highly anticipated Safer Technologies Program (STeP) Guidance Document.
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News

Lessons Learned: 2020 RAPS U.S. and Euro Convergence

RQM+ sponsored both RAPS U.S. and Euro Convergence conferences in 2020 and we also led and provided subject matter experts for two panel discussions. Our experts pulled together the highlights from both conferences and summarized them by category for our readers.
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