QA/RA Consulting, Auditing & Training
EUDAMED Is Live – and It’s Mandatory For years, EUDAMED was the regulatory equivalent of “coming soon.” Now that it’s here, it is operational for medical device and IVD companies that are marketing products in the EU and, for many companies, it is no longer a future project. It is now a part of a […]
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The EU MDR Is Not Being Weakened ├óΓé¼ΓÇ£ It├óΓé¼Γäós Being Reengineered: Why the Commission├óΓé¼Γäós 2025 Proposal Marks a Strategic Reset, Not a Rollback After four turbulent years of MDR implementation, on December 16, 2025, the European Commission reached a rare conclusion: Europe does not suffer from insufficient regulation ├óΓé¼ΓÇ£ it suffers from insufficient proportionality. From […]
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PSUR PMSR Requirements in EU MDR In this article we will address these common questions: What├óΓé¼Γäós the difference between a PSUR and a PMSR? Which one is required for our devices? How are they submitted and to whom? How often do they need to be updated? How do they relate to the├é┬áPMS plan? What├óΓé¼Γäós the […]
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Navigating the FDA QMSR Transition: Insights for Compliance (5-Part Microlearning Video Series) Audience: Medical device professionals, quality managers, and compliance teams Why You Should Care (Yes, You) The FDA has officially moved on from its 25‑year‑old QSR, replacing it with the ISO 13485‑aligned QMSR. That shift isn’t theoretical anymore—it’s enforceable, and inspection expectations have changed accordingly. Click […]
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Navigating the Impact of EU Regulation 2024/1860 on Medical Device and IVD Manufacturers Worried about supply chain delays and transition timelines in the medical device industry? You├óΓé¼Γäóre not alone: the EU has taken a step forward toward addressing medical device availability. Regulation EU 2024/1860, published in 2024, focuses on critical supply chain issues and extends […]
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Medical Device Cybersecurity Requirements Under the EU MDR The European Medical Device Regulation (MDR) introduced a more rigorous approach to medical device cybersecurity, making it a safety requirement for medical devices (and IVDs under the EU IVDR). With AI making its way into the healthcare space and more devices relying on connectivity to function, hackers […]
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