Heyer Regulatory Solutions LLC



The expert source for global regulatory strategies.

News and Events




Learn "How to Enhance Your Medical Device Approval Process" - Sheila Hemeon-Heyer interview with Scott Nelson of Medsider.com 

    See http://medsider.com/interviews/how-to-enhance-your-medical-device-approval-process-interview-sheila-hemeon-heyer-president-heyer-regulatory-solutions/


Past Presentations


Meeting the Challenges of Today's Changing Regulatory Environment, CINDE Life Sciences Forum, San Jose, Costa Rica, March 19, 2013.


Hot Topics in FDA Regulatory Affairs, FDLI Medical Device Regulatory, Compliance and Litigation Conference, Washington, DC, March 4, 2013.


Changes in FDA's 510(k) Program, Japan Association for the Advancement of Medical Equipment (JAAME), Tokyo, Japan, October 23 and 25, 2012.


Status of Medical Device User Fee Reauthorization, FDLI Medical Device Regulation and Litigation Conference, July 18, 2012.

Why Do FDA-Regulated Medical Product Companies Report Going Abroad to Develop New Products?  FDLI Annual Conference, Washington, DC, April 24, 2012.
US FDA 510(k) Program:  FDA Changes and Impact to Industry, CABA MDDI Conference, Waltham, MA, December 3, 2011.


FDLI Dialogue on IOM 510(k) Report:  Preliminary Thoughts from Industry, Food and Drug Law Institute, August 4, 2011.


Postmarket Surveillance Strategies Across FDA:  Center Updates and Strategies to Assure Compliance and Mitigate Litigation, Food and Drug Law Institute Annual Conference, April 5, 2011.


510(k) Reform:  Partnering with CDRH for Process Improvements that Foster Innovation and Benefit Public Health, Massachusetts Medical Society (MassMedic), Waltham MA, December 1, 2010.


Hot Topics in Advertising & Promotion, Food and Drug Law Institute Advertising & Promotion Conference, September 20, 2010.


Regulatory Implications of Device Design and Process Changes, FDA/Xavier MedCon 2010, Cincinnati, Ohio, May 5, 2010.


FDA’s Signal Analysis and Escalation Program, Food and Drug Law Institute Annual Conference, Washington, DC, April 23, 2010.


Strategies for Building an Effective Postmarket Surveillance Program, Medical Device Quality and Compliance Congress, Cambridge, MA, June 5, 2009.


Best Practices for a Comprehensive Postmarket Surveillance System, Regulatory Affairs Professional Society Annual Conference, Boston, MA, September 16, 2008.