Job title, company, and location:
Partner, Hogan Lovells Cadwalader, Washington, DC, USA
Biography:
Michael is a Partner at Hogan Lovells Cadwalader. His practice specialises in the medical device area with an emphasis on post-market compliance and enforcement matters, including the FDA’s Quality Management System Regulation, adverse event reporting, and field action requirements. His experience includes assisting in the defence of criminal investigations by the US Department of Justice, responding to FDA Warning Letters and Form 483s, conducting internal investigations of alleged violations of federal regulations, reviewing and drafting standard operating procedures, assisting clients with import and export issues, conducting regulatory due diligence and assistance with negotiation of corporate mergers and acquisitions and initial public offerings, and providing general advice on a variety of device-related regulatory issues. His expertise has been recognised in Chambers USA and LMG Life Sciences. Mr Heyl is a member of the District of Columbia Bar and the Maryland State Bar.
Areas of expertise:
Medical device compliance and enforcement; Quality Systems, QMSR, ISO 13485 (certified auditor); recalls; adverse event reporting; internal/whistleblower investigations; due diligence; advertising and promotion
Regulatory jurisdictions covered:
USA
Education:
J.D., (Magna Cum Laude) Catholic University of America (2002)
B.S., Political Science, University of Delaware (1993)
Certifications:
Quality Systems, ISO 13485/9001, MDSAP, Exemplar Global, DEKRA
Published books:
- Medical Device Development: Regulation and Law, Editor, co-author (Parexel)
- Medical Devices: A Practical Guide, Contributing Author (PLI)
- A Practical Guide to FDA’s Food and Drug Law and Regulation, Contributing Author (FDLI)
- Food and Drug Law and Regulation, Contributing Author (FDLI)
Professional/social links:
LinkedIn: https://www.linkedin.com/in/michael-heyl-a7a3b133/
