Michael S. Heyl
As a Hogan Lovells partner in the firm's accomplished Medical Devices Practice, 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 start-ups develop and implement post-market 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 U.S.
He has assisted in the defense of criminal investigations by the U.S. Department of Justice, 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. He has been involved with numerous transactions ranging from multibillion dollar acquisitions to the negotiation of supply and distribution agreements.
Mike is a frequent speaker on regulatory compliance and enforcement issues in the device industry. He also serves as the device representative on the Hogan Lovells Life Sciences Steering Committee.
Areas of Focus
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 U.S.
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28 September 2016