QA/RA Consulting, Auditing & Training
Stop Calling It Risk Based. Start Proving It. Most companies say that their quality management systems are risk based. FDA will ask you to prove it. Under the FDA’s Quality Management System Regulation (QMSR), that distinction is getting harder to ignore. As inspections evolve, the question isn’t just whether risk is documented. Instead, it’s whether […]
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ISO 14971 and the Basics of Medical Device Risk Management Explained This is the first installment of a 3-part blog series on risk management. If you already know the basics, skip to the second post on├é┬árisk management planning. We’ve combined all three posts into one easy-to-read PDF, plus added some extras. Download it here. From […]
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Evaluating and Accepting Medical Device and IVD Residual Risk Medical device manufacturers and regulators generally have different goals, but one thing they have in common is a desire to make sure devices are safe and effective. To achieve that, regulatory managers often spend a substantial amount of time analyzing, evaluating, and controlling all manner of […]
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ISO 14971 Certification Plus 5 More Medical Device Risk Management Myths ISO 14971 has been the de facto international standard for medical device risk management for more than 20 years. If you want to sell your devices in the US or Europe, the standard will become an absolute necessity in your quest to obtain FDA […]
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EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8 Clients often ask us what has changed with regard to vigilance reporting in the European Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). Basically, not much, but there are a few important changes you should be aware of. First, it is important to […]
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ISO 14971:2019: Understanding the Current Version of ISO 14971 The third edition of ISO 14971 was released in December 2019 and replaced ISO 14971:2007. Although the risk management process itself remains largely unchanged, there are important clarifications and updates in ISO 14971:2019 to be aware of. The third edition is structured with 10 clauses and […]
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