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 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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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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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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In-Depth: Europe CE Marking Medical Device Approval and Compliance
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Introduction to the Israel AMAR Medical Device Registration Process
Israel is a small country with significant medical device needs. Medical devices in Israel are regulated by AMAR and the registration process relies
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In Depth: Japan Medical Device Approval and Compliance
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Introduction to Japan's Medical Device Approval Process
Japan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend more
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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
Read More