Heyer Regulatory Solutions LLC



The expert source for global regulatory strategies.


Sheila Hemeon-Heyer, JD, RAC


Founder & President

Sheila Hemeon-Heyer formed Heyer Regulatory Solutions in 2010 in order to provide medical device, combination product, and in vitro diagnostic companies with an experienced choice for their global regulatory needs.  Ms. Hemeon-Heyer began her regulatory career at FDA where she was a Scientific Reviewer in the CDRH Office of Device Evaluation and was responsible for reviewing 510(k), IDE and PMA applications for orthopedic, physical medicine and surgical devices.  After leaving FDA, Ms. Hemeon-Heyer was a Senior Consultant, then Director of Regulatory Services for Medical Device Consultants, Inc. (MDCI), providing regulatory, clinical and quality consulting services to the medical device and in vitro diagnostic industries and managing complex projects across the medical product lifecycle.  She joined Boston Scientific Corporation (BSC) in 2005 as Vice President, Global Regulatory Affairs.  She holds a BS in Biomedical Engineering from Boston University, an MS in Biomechanics from the University of Massachusetts at Amherst, a JD from Western New England College School of Law, is Regulatory Affairs Certified and a Fellow of the Regulatory Affairs Professional Society, and serves on the Board of Directors for the Food and Drug Law Institute (FDLI).

Experience Counts


Heyer Regulatory Solutions brings to you the experience of:


  • Working within FDA - knowing what information FDA reviewers need to make their decisions


  • Working with a wide variety of companies to achieve the right solutions for their products


  • Hands on experience preparing all types of regulatory submissions, including IDE, 510(k), PMA, HDE, RFD, reclassification petitions, combination products, EU technical files, EU design dossiers, Canadian License Applications, and more


  • Guiding company scientific and medical experts to get the most out of meetings with Regulatory Agencies


  • Building regulatory systems and procedures to help assure companies stay on the right side of compliance


  • Knowing the latest changes in global regulations and agency expectations to make sure that you are not caught unawares