Regulatory

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It Takes Avania Brochure

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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

White Paper

Environmental and Social Considerations for Medical Devices

White Paper

Final FDA Guidance – Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

White Paper

Changes to Medical Device Regulations in China

White Paper

Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications

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