Resources

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

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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Introduction to Brazil's Medical Device Approval Process
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
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In Depth: Brazil Medical Device Approval and Compliance
Brazil is one of the fastest growing device markets in the world. It’s now among the top 10 markets and spends as much on healthcare as the UK.
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Introduction to Canada's medical device registration process
Canada is a well-established but lucrative market for medical devices. It has one-fifth the population of Brazil, but spends nearly as much on
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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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China Medical Device Market Overview
With over 1.3 billion residents, China has one of the world's largest medical device markets. Medical device manufacturers around the world are
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Introduction to Colombia's Medical Device Approval Process
Colombia has over 48 million residents and is a very strong market for foreign medical device manufacturers. Interested in entering this market? This
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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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