Area of focus

Postmarket Compliance and Enforcement Actions

It’s a reality that medical devices intended to help patients can sometimes cause harm or malfunction. When that happens, how is your company prepared to deal with applicable regulatory requirements?

Hogan Lovells helps companies navigate the complex framework of reporting adverse events to regulatory bodies and...

Representative experience

We establish regulatory training programs to educate internal units of major medical device and combination product companies about adverse event reporting requirements and procedures.

We have assisted clients in responding to enforcement actions related to inadequate adverse event reporting and helped develop procedures to protect against future enforcement.

Helped clients conduct retrospective reviews of their files to assess their obligations in submitting Medical Device Reports to the FDA and bring their reporting up to date.

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