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How ISO 13485:2016 Impacts Medical Device Companies
The new ISO 13485 revision is finally here and, for medical device manufacturers, this is big news. You probably have plenty of questions about how
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Understanding Europe's New Medical Device Regulation - MDR 2017/745
You've probably heard that Europe's well-established medical device regulations are about to change. And you probably have a lot of questions. What
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Understanding Europe's New IVDR 2017/746
It's finally here. The European Commission's new In Vitro Diagnostic Regulation (IVDR 2017/746) will address several weaknesses of the IVDD and bring
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How device companies can prepare for a no-deal Brexit
How device companies can prepare for a no-deal Brexit
As Brexit Day approaches, the outcome of the UK’s planned withdrawal from the EU seems more uncertain than ever. One thing is definitive: a no-deal (
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CE Marking Conformity Assessment for Medical Devices
Ready to sell your medical devices in Europe? First, you must comply with Europe’s medical device regulations. But instead of a one-size-fits-all
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Preparing a European CE Technical File for a Medical Device
Want to sell your medical device in Europe? If the answer is yes, you probably have a lot of questions about one of the key elements of the European
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Implementing a Medical Device Post-Market Surveillance Program
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system
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Regulations for Companion Diagnostics in the US and EU
Are you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision
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ISO 13485:2016 and the new Risk-based Approach
The new ISO 13485:2016 quality management system standard for medical devices introduces lots of new changes and concepts. However, its emphasis on
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