Regulatory

White Paper

The Benefits of a Breakthrough: The Advantages of FDA Breakthrough Designation for Patients and Medical Device Manufacturers

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Beyond the CE Mark: How to Collect Clinical Evidence to Ensure EU MDR Compliance

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Navigating the Pre-Market EU MDR Journey

Brochure

It Takes Avania Brochure

Blog

EU Medical Device Regulation 2017/745 – First Formal Amendment, Delaying Date of Application

May 4, 2020

Blog

Post-market surveillance under a “522 order” — why, what, and how?

April 9, 2020

Blog

Medical apps under the new European MDR

April 6, 2020

Blog

Clinical Evaluation Plan – The Start of All Clinical Evaluations

April 6, 2020

White Paper

Global Regulatory Update: A Trend towards Harmonization and Enforcement

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Environmental and Social Considerations for Medical Devices

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