About
https://www.mcmregulatory.com
Activity
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Congratulations to Martha Sheets on completing week one at Emory University School of Medicine.
Congratulations to Martha Sheets on completing week one at Emory University School of Medicine.
Liked by Michael Morton
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FDA now has seat at the table on two of the most influential groups in establishing how #medtech gets paid for in the US. Douglas Kelly, MD from the…
FDA now has seat at the table on two of the most influential groups in establishing how #medtech gets paid for in the US. Douglas Kelly, MD from the…
Liked by Michael Morton
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Looking forward to this Quality Workshop on the 6th of August. What an opportunity to interact with thought leaders from industry and the FDA.
Looking forward to this Quality Workshop on the 6th of August. What an opportunity to interact with thought leaders from industry and the FDA.
Shared by Michael Morton
Experience & Education
Licenses & Certifications
Volunteer Experience
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Member Board Of Directors
Regulatory Affairs Professionals Association
- 3 years
Science and Technology
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Advisory Board Member Stephenson School of Biomedical Engineering
University of Oklahoma
- Present 7 years 9 months
Education
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Advisory Board Member, Master of Science in Health Sciences in Regulatory Affairs Program
George Washington University
- Present 12 years 7 months
Education
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Advisory Board Member, Regulatory Science Program
University of Southern California
- Present 14 years 7 months
Education
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Advisory Board Member, Regulatory Affairs and Services Program
St. Cloud State University
- Present 16 years 1 month
Education
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Professional Associate
Fort Lewis College
- Present 6 years 7 months
Education
The Professional Associates of Fort Lewis College (PA) was created to serve as an advisory resource for the president on matters vital to the college. In support of the mission of FLC, PA today provides assistance for a number of administration, faculty, student and college/town programs and activities. One of the organization's objectives is to provide resources to FLC faculty and staff.
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Scientist Reviewer
Congressionally Directed Medical Research Program
- 1 month
Health
Served as technical reviewer for the Psychological Health/Traumatic Brain Injury Research Program.
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Board Member
Adaptive Sports Association
- Present 3 years 2 months
Health
The mission of the Adaptive Sports Association (ASA) is to provide outdoor, sport, and recreational experiences for people with disabilities. These activities are provided regardless of individual financial limitations and create an atmosphere for learning and enhancing self-esteem.
Publications
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A new paradigm for obtaining marketing approval for pediatric-sized prosthetic heart valves
Journal of Thoracic and Cardiovascuar Surgery
Abstract
OBJECTIVE: Congenital heart valve disease is one of the most common abnormalities in children. There are limited technological solutions available for treating children with congenital heart valve diseases. The aim of this study is to provide the details of the consensus reached in terms of pediatric definitions, design approach, in vitro testing, and clinical trials, which may be used as guidance for developing prosthetic heart valves for the pediatric indication.
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Preclinical testing for aortic endovascular grafts: Results of a Food and Drug Administration workshop
Journal of Vascular Surgery
Abstract
Background: Since their introduction into clinical trials in the United States, endovascular aortic grafts have shown various types of problems. Although details of design and construction vary between different endovascular grafts and failure modes have had a variety of causes and clinical effects, the inability of preclinical testing to predict these failures remains common to all endovascular grafts. The need to improve preclinical testing in an attempt to reduce clinical device…Abstract
Background: Since their introduction into clinical trials in the United States, endovascular aortic grafts have shown various types of problems. Although details of design and construction vary between different endovascular grafts and failure modes have had a variety of causes and clinical effects, the inability of preclinical testing to predict these failures remains common to all endovascular grafts. The need to improve preclinical testing in an attempt to reduce clinical device failures resulted in a Food and Drug Administration-sponsored workshop on endovascular graft preclinical testing held in Rockville, Md, from July 31 to August 1, 2001.
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Honors & Awards
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Founder's Award
Regulatory Affairs Professional Society
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.
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Fellow [of the] Regulatory Affairs Professional Society (F.R.A.P.S]
Regulatory Affairs Professional Society
The RAPS Fellows program recognizes senior regulatory professionals, with a minimum of 15 years of regulatory experience, for their continued significant contributions and leadership in the advancement of the profession.
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Advisory Committee Service Award
U.S. Food and Drug Administration
In recognition of distinguished service [to the] Circulatory System Devices Panel, Medical Devices Advisory Committee, May 2001 to June 2005.
More activity by Michael
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Please help us welcome Mark Spreeman to our team!
Please help us welcome Mark Spreeman to our team!
Liked by Michael Morton
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Facilitated a panel on Risk Management (“Risky Business”) at the MDIC Quality Excellence Summit in Boston yesterday. Distinguished panelists Erin…
Facilitated a panel on Risk Management (“Risky Business”) at the MDIC Quality Excellence Summit in Boston yesterday. Distinguished panelists Erin…
Liked by Michael Morton
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Today marks the 25th anniversary of the Helex Septal Occluder (https://lnkd.in/gRrzGbUE) First-In-Human milestone #FIH, the first product of my…
Today marks the 25th anniversary of the Helex Septal Occluder (https://lnkd.in/gRrzGbUE) First-In-Human milestone #FIH, the first product of my…
Liked by Michael Morton
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Pantheon Vision's Marty Chomiak and Daniel Stonko thanks J.P. Morgan Life Sciences for hosting the Baltimore Life Sciences Networking Reception. It…
Pantheon Vision's Marty Chomiak and Daniel Stonko thanks J.P. Morgan Life Sciences for hosting the Baltimore Life Sciences Networking Reception. It…
Liked by Michael Morton
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Participated in a panel “ Championing a culture of quality” with Steve Silverman, Patterson (Pat) Shafer, Sara Sulfridge, Jackie Torfin and Zillery…
Participated in a panel “ Championing a culture of quality” with Steve Silverman, Patterson (Pat) Shafer, Sara Sulfridge, Jackie Torfin and Zillery…
Liked by Michael Morton
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I am excited to share that I have been promoted to Vice President of Health Economics, Policy, and Reimbursement (HEPR) at Medtronic. I couldn’t be…
I am excited to share that I have been promoted to Vice President of Health Economics, Policy, and Reimbursement (HEPR) at Medtronic. I couldn’t be…
Liked by Michael Morton
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Samsung continues to advance digital health!
Samsung continues to advance digital health!
Shared by Michael Morton
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It's an exciting time for Samsung's Digital Health team right now. I was honored to represent the team on stage at our July 2024 #GalaxyUnpacked…
It's an exciting time for Samsung's Digital Health team right now. I was honored to represent the team on stage at our July 2024 #GalaxyUnpacked…
Liked by Michael Morton
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