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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 is 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.
Recently, Mike was awarded the 2022 Catholic University of America Columbus School of Law Distinguished Alumni award. The award recognizes outstanding alumni for their individual achievements, contributions to their industries or professions, service to their community, and demonstrated loyalty to Catholic Law.
Assisted numerous clients to prepare for, defend, and/or respond to domestic and international inspections and enforcement actions.
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.
Assisted a large company to conduct an internal investigation and remediation plan following a whistleblower complaint.
Assisted a medical device manufacturer with a review of promotional materials and remediation strategy following FDA action.
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.
Assisted numerous device manufacturers and companies from other industry sectors in obtaining Emergency Use Authorizations during the COVID-19 pandemic.
- J.D., The Catholic University of America, Columbus School of Law, magna cum laude, 2002
- B.A., University of Delaware, 1993
- District of Columbia