The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification
The Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification The Medical Device Single Audit Program (MDSAP) is a cooperative effort between the medical device regulators in the US, Canada, Japan, Australia and Brazil. Argentina, South Korea, and Singapore participate as affiliate members. The challenges of preparing for your first MDSAP […]
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European IVDR PDF + Table of Contents for 2017/746
European IVDR PDF + Table of Contents for 2017/746 Weighing in at 157 pages and 85,000 words, the new European IVD Regulation requires serious concentration for regulatory professionals. We’ve made this daunting task a little easier by adding a fully linked, easy-to-navigate Table of Contents to the IVDR. Just download the IVDR PDF and save […]
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What is the EU Person Responsible for Regulatory Compliance (PRRC) role in the EU MDR?
What is the EU Person Responsible for Regulatory Compliance (PRRC) role in the EU MDR? Compliance with European regulations has become progressively more complex, especially with the introduction of the EU Medical Device Regulation (2017/745) and In Vitro Diagnostic Regulation (2017/746). European regulators want to make sure companies always have a qualified regulatory expert at […]
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European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14
European Medical Device Importers and Distributors Have New Regulatory Responsibilities Under EU MDR Articles 13 and 14 When the European Medical Device Regulation (2017/745) was published in 2017, few medical device importers and distributors were aware of the new requirements that would be placed on them. The EU MDR elevates the importance of all economic […]
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Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits
Understanding the Risks Posed by Your Medical Device Suppliers and How Supplier Quality Fits ├é┬á With each passing decade, the world economy becomes more interconnected. It is not unusual for today’s medical device manufacturer to source circuit boards from South Korea, display screens from China, injection-molded components from Mexico, and precision bearings from Germany, all […]
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The US FDA Case for Quality (CfQ): What It Is and Why You Should Care
The US FDA Case for Quality (CfQ): What It Is and Why You Should Care For decades, the medical device industry has largely viewed the US Quality System Regulation (QSR) as a regulatory speedbump on the path to market access. Despite the regulation’s name, product quality has typically taken a back seat to regulatory compliance […]
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