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COVID-19 Report for Life Sciences and Health Care Companies
05 April 2021
PartnerWashington, D.C.
Email mike.heyl@hoganlovells.com
Phone +1 202 637 5456
Fax +1 202 637 5910
LanguagesEnglish
Practice groupGlobal Regulatory
Mike Heyl helps medical device companies navigate myriad regulatory and business matters. He guides clients through U.S. Food and Drug Administration (FDA) regulations, requirements, and compliance issues. These issues include FDA's Quality System Regulation (QSR); adverse event reporting; recall reporting requirements; FDA inspections and enforcement actions, such as Warning Letters; defense strategies; and corrective and remedial action plans.
He represents large multinational corporations facing FDA and criminal enforcement, and helps small startups develop and implement postmarket compliance programs. Because he understands FDA's requirements for importing and exporting medical devices, Mike is frequently called on to negotiate the release of detained goods being imported to the United States.
He has assisted in the defense of criminal investigations by the U.S. Department of Justice (DOJ), conducted internal investigations of whistleblower complaints, and prepared strategies for resolving such issues.
Mike also works with device companies in conducting regulatory due diligence and negotiating corporate mergers and acquisitions and initial public offerings (IPOs). He has been involved with numerous transactions ranging from multibillion-dollar acquisitions to the negotiation of supply and distribution agreements.
Mike recently became an ISO 9001:2008 certified internal auditor with focus on ISO 13485:2016 and Medical Device Single Audit Program (MDSAP).
Mike is a frequent speaker on regulatory compliance and enforcement issues in the device industry. He also serves as the device representative on our Life Sciences steering committee.
U.S. Regulatory Star
LMG Life Sciences
Education
J.D., The Catholic University of America, Columbus School of Law, magna cum laude, 2002
B.A., University of Delaware, 1993
Bar admissions and qualifications
District of Columbia
Maryland
Assisted numerous clients to prepare for, defend and/or respond to domestic and international inspections.
Assisted a brand name device company with the acquisition of several medical device manufacturers.
Assisted a large multinational corporation with strategy and defense with an FDA enforcement action involving a highly publicized health risk.
Assisted a medium-sized medical device manufacturer in preparing corrective action strategy and drafting a response to an FDA inspection.
Successfully negotiated the release of devices being detained upon import to the United States.
Assisted a small-sized medical device manufacturer in responding to FDA inspections and grand jury subpoena.
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