Heyer Regulatory Solutions LLC



The expert source for global regulatory strategies.


What They Are Saying

"Sheila provided our company exceptionally valuable knowledge and leadership as we were struggling in the early stages of a consent decree.  All systems needed to be reworked and Sheila's experience and hard work helped us to update and make conpliant our MDR, recall decision and 510(k) systems.  She has also gained 510(k) clearance for several of our complicated systems - quicker than we ever could have imagined.  We will be forever grateful."


Gail Tisack, Chief Legal Counsel
Terumo Cardiovascular Systems
“I worked with Sheila several times over the last 10 years: my only disappointment was when she left consulting to take a full time position to lead worldwide regulatory affairs at Boston Scientific. She provided to BioSphere Medical the regulatory guidance that led to FDA clearance of our Embosphere product for Uterine Fibroid Embolization; she also did an outstanding job driving the regulatory due diligence process during the negotiation of a strategic partnership, working with me at the negotiating table. I went back to Sheila when we started Pluromed, Inc., and she designed from scratch the regulatory strategy that led a couple of years later to our first FDA clearances...for what was and still is a completely new and unique medical device technology. Sheila is very bright, very strategic; and yet detailed, precise and very reliable in the execution of the strategy. I am of course delighted she is back in consulting!” 

Jean Marie Vogel, Chief Executive Officer



“Sheila is the best regulatory person I’ve ever worked with.  Pluromed brought Sheila on board to help get our LeGoo PMA approved. She came up to speed immediately and coached management at a critical time during the company’s growth.  Interacting closely with FDA, Sheila was able to resolve all issues and gain FDA approval faster than we thought would be possible.  I highly recommend Sheila to get the job done.”


 Jim Wilkie, Chief Operating Officer


"I have had the pleasure and privilege to work closely with Sheila over the last 4+ years; she has been my go-to person for regulatory questions. Sheila's depth and breadth of regulatory knowledge, both U.S. and O.U.S., is comprehensive. However, in the rapidly changing atmosphere of the medical device industry, extensive knowledge is often not enough. Sheila's conceptual understanding of the regulatory environment allows her to interpret the regulations in a consistent and reliable way, and to apply this knowledge to the actual business issues that arise. More so, her insights into where upcoming regulatory trends are going have guided us and allowed us to stay ahead of changes, maximizing our compliance and minimizing risks. Sheila is clearly among the top regulatory talents in the medical device industry, and I recommend her with enthusiasm and without reservation."   

Jeff Hersh, MD, PhD, Chief Medical Officer

GE Healthcare



“I had the pleasure of working with Sheila for several years, while she was at MDCI.  She was a virtual one man army helping us define a regulatory path toward approval of our device for a very new indication, planning and organizing our clinical investigation, managing relationships with FDA, interpreting and positioning clinical data.  She’s diligent, intelligent, adaptable and thorough.  I recommend her without hesitation.”

Jon McGrath, CEO

Neograft Technologies



“Sheila is a scholar in FDA medical device regulations and their interpretations. This knowledge, coupled with her having worked for the FDA and industry, makes her uniquely qualified to assist medical device manufacturers." 

Abe Mathews, Vice President Regulatory Affairs and Quality Assurance

Coherex Medical


"Sheila was instrumental in successfully navigating through many FDA challenges for our small size company.  Without her expertise, the company would have been faced with a lengthy FDA review process that would have detrimentally affected the company’s timelines, goals and budget.  Through her breadth of regulatory experience and phenomenal negotiation and communication skills when dealing with FDA, Sheila has the right skills to help you succeed at any regulatory challenge you may face.  Sheila is the first person I think of when colleagues ask me for a recommendation."


Sharon Timberlake, Vice President Regulatory Affairs

Palomar Medical