Michael S. Heyl

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.