Ashland MA, February 1, 2022. MEDIcept Inc. announced today that Kim Trautman has been appointed as Managing Director and Vice President of the company. An experienced medical device, IVD, and combination product expert, Trautman worked at the US Food and Drug Administration (FDA) for 24 years and continues to work with Regulatory Agencies around the globe.
Ms. Trautman will be an integral part of the MEDIcept executive management team in this role. She will provide strategic client consulting services, develop business relationships with new clients, and lead the expansion of the MEDIcept Training Immersion Program, developing the next generation of medical device consultants.
According to F. David Rothkopf, President of MEDIcept, “We are honored to have Kim join our firm. She brings value and a trusted voice on critical matters to our clients with her wealth of regulatory experience and knowledge. Her mentoring skills and experience will assist us with the individual growth of our associate consultants.”
An expert in global medical device regulations, she wrote and harmonized the current FDA Quality System Regulation. In addition, Trautman developed the International Medical Device Single Audit Program (MDSAP) and consortium from conception through its pilot. After retiring from FDA, she established an Authorized MDSAP Auditing Organization and launched a new Notified Body for EU IVDR/MDR Designation.
“I am extremely happy to be working with MEDIcept. I am excited to be working side by side with several colleagues that I have known throughout my 30-year career,” said Kim Trautman. “I am equally excited about MEDIcept’s passion in developing young quality and regulatory professionals as part of the MEDIcept Immersion Program. Mentoring the next generation of industry professionals is an important personal goal.”
Trautman received her M.S. of Biomedical Engineering from the University of Virginia and her B.Sc. of Molecular Cell Biology from the Pennsylvania State University. She currently serves on the Board of Directors at the Regulatory Affairs Professionals Society (RAPS) and has been on TC 210 Working Group 1 for ISO 13485 since its 1994 inception. She also serves as the College of Engineering Vice Chair for the Industry & Professional Advisory Council at Penn State.
MEDIcept is an international medical device, IVD, combination product, and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, Clinical, Auditing, and Educational services. Our experienced team of former FDA, Notified Body, and industry experts will work with you to efficiently develop or remediate a quality system, create a regulatory strategy, or establish a clinical trial, to meet your specific needs.