Resources

Get the latest white papers, process charts, and other resources about medical device regulatory affairs, quality assurance, human factors, and cybersecurity requirements.

Introduction to Clinical Evaluation Reports (CER) for Europe
Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device,
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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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Watch our recent webinar on the European In Vitro Diagnostic Devices Regulation
WATCH NOW: Europe's New IVDR 2017/746
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic
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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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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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Register for our webinar: Post Market Surveillance & PMCF under the European MDR
WATCH NOW: PMS & PMCF under the European MDR
Post-market surveillance (PMS) is complex and often misunderstood by device manufacturers. Europe's new Medical Devices Regulation (MDR) adds to the
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ISO 13485:2016: Six Key Differences for Medical Device Companies
The publication of ISO 13485:2016 introduced significant changes for device manufacturers around the world. Some changes are specific, while others
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What To Expect From Your Regulatory Representative
Are you hoping to export your device to other medical device markets? If so, most countries require you to appoint an in-country representative if
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Learn about the European Directives and Regulations which apply to medical devices
Medical Device Regulations in Europe
All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting
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