In the News

Photo by ijeab/iStock / Getty Images

Photo by ijeab/iStock / Getty Images

Morton recipient of Regulatory Affairs Professional Society Founder’s Award for 2021: The Founder’s Award recognizes exemplary regulatory professionals and is the profession’s highest award. Honorees have shaped regulatory policy and practice; made a positive impact on the profession through education and mentoring; volunteered time to leadership pursuits such as serving on the RAPS board or Fellows program; promoted healthcare and patient well-being; advanced regulatory agility and raised awareness of the value of regulatory.

https://www.raps.org/membership/awards/meet-the-raps-awardees

Why Regulatory Affairs Deserves a Seat at the Table. Mastering Medical Device Podcast Episode Featuring Michael Morton.

https://www.masteringmedicaldevice.com/episodes/morton

Let’s Build This: Best Practices for Utilizing External Regulatory Expertise - September 2020 - Building a regulatory submission is much like building a house and requires recognition of the order of steps that need to take place.

https://www.mpo-mag.com/contents/view_online-exclusives/2020-09-25/lets-build-this-best-practices-for-utilizing-external-regulatory-expertise/

Michael C. Morton Announces MCM Regulatory Consulting, LLC - August 2017 - After more than 30 years working in the medical device industry, Michael C. Morton has established MCM Regulatory Consulting, LLC. Bringing extensive experience from various regulatory affairs roles with leading device companies, Morton is looking to work with companies that need experience in establishing a successful regulatory strategy and plan. His extensive work with the U.S. Food and Drug Administration (FDA) has led him to approaching the agency as a partner and he brings a depth of experience in FDA Advisory Committees, including having served as an industry representative of the circulatory devices advisory panel. Morton can be reached via Michael@MCMRegulatory.com.

Innovation and Technology Panel - September 19, 2016 - 

Patient Access to High-Risk Devices for Unmet Medical Needs - A Summary of a Meeting on Exploring Access to Innovative Devices for Patients Without Alternatives - January 30, 2015 - http://www.pewtrusts.org/~/media/legacy/uploadedfiles/phg/content_level_pages/issue_briefs/meddevicesinnovationmtgsummaryv2pdf.pdf

 

Surviving Your Advisory Panel Meeting: Medtronic's VP of Global Regulatory Gives 12 Tips - October 4, 2013 - http://www.raps.org/regulatoryDetail.aspx?id=9498   

 

Medtronic VP offers 3 steps for medical device companies to prepare for an FDA submission panel meeting successfully - MedCity News, September 24, 2013 - http://medcitynews.com/2013/09/three-key-strategies-help-device-company-prepare-fda-submission-panel-successfully/

 

Publications

 

A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves - The Journal of Thoracic and Cardiovascular Surgery, October 2013 (Volume 146, Issue 4, Pages 879-886) - http://www.jtcvsonline.org/

 

Preclinical testing for aortic endovascular grafts: Results of a Food and Drug Administration workshop - Journal of Vascular Surgery, May 2002 (Volume 35, Issue 5, Pages 1022-1028) - http://www.jvascsurg.org/