Michael S. Heyl Joins the Editorial Board of the Journal of Medical Device Regulation
The Journal of Medical Device Regulation (JMDR) is pleased to announce the appointment of Michael S. Heyl to its Editorial Advisory Board. A recognised expert in medical device regulation, Mike brings a wealth of knowledge and hands-on experience in navigating US Food and Drug Administration (FDA) regulations, compliance strategies, and enforcement matters.
Mike helps medical device companies – ranging from multinational corporations to startups – address FDA Quality System Regulation compliance, adverse event and recall reporting, FDA inspections, and enforcement actions. His expertise in post-market compliance and FDA import/export requirements makes him a valuable addition to the JMDR’s Editorial Advisory Board.
Among his many other experiences, Mike has assisted numerous clients with domestic and international inspections and enforcement actions; strategy and defence with FDA enforcement action involving highly publicised health risks; preparing corrective action strategy and drafting a response to an FDA inspection; review of promotional materials and remediation strategy following FDA action and much more.
Mike is also an ISO 9001:2008 certified internal auditor with a focus on ISO 13485:2016 and the Medical Device Single Audit Program.
Victoria Clark, Editor of the JMDR, welcomed his appointment:
‘We are delighted to have Mike Heyl join our Editorial Board. His deep understanding of US regulations, combined with his strategic approach to compliance and enforcement matters, will provide invaluable insights to our readers. His expertise will further strengthen the Journal’s role as a trusted resource for regulatory professionals worldwide’.
Mike’s appointment aligns with the Journal’s commitment to provide expert-driven content that supports professionals in the ever-evolving medical device regulatory landscape.
About the Journal of Medical Device Regulation
The Journal of Medical Device Regulation reaches regulatory professionals around the world and provides them with in-depth articles on current regulatory matters as well as topical information on international regulatory changes. In addition to publishing review and discussion articles by opinion leaders from the device community, the Journal summarises the global news headlines and provides useful reference information in the form of charts and briefing documents. The Journal is a quarterly, subscription-only e-journal published by Global Regulatory Press.
For more information on the Journal of Medical Device Regulation, please contact Marija Capek
(tel: +44 7916 443811; email: sales@globalregulatorypress.com) or visit GlobalRegulatoryPress.com.
