Executive Vice President, Medical Device International Services,
Ms. Trautman is a medical device and in vitro diagnostic executive vice president with 26 years of experience working at the U.S. FDA Center for Devices and Radiological Health (CDRH) and working with regulatory agencies around the globe. In her roles, she has executed medical device regulatory services, including developed a formal education/training business, as well as an Authorized Medical Device Single Audit Program (MDSAP) Auditing Organization and a new Notified Body in Ireland for EU IVDR/MDR Designation.
Ms. Trautman wrote and harmonized the U.S. FDA Quality System Regulation 21 CFR § 820 and has served on the international authoring group of ISO 13485 since inception. While at U.S. FDA, she conceived and developed the MDSAP international consortium of five global regulators, as well as its many foundational documents. She is a 25-year veteran of the Global Harmonization Tasks Force (GHTF) and foundational member of the International Medical Device Regulators Forum (IMDRF). Her last position at CDRH was Associate Director for International Affairs within the Office of the Director.
Currently, at NSF International in the Health Sciences Division, Ms. Trautman is leveraging her over 30 years of medical device sector experience to expand international regulatory affairs and compliance services for NSF International global clients.