Resources

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

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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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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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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Introduction to European CE Marking for medical devices
Europe is the world's second-largest medical device market with 500 million people, 20+ languages, 32 countries and (fortunately) only one approval
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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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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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14971 risk management webinar
WATCH NOW: Risk Management according to EN ISO 14971:2012
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
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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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