Mindy McCann, PhD
VP Regulatory Compliance US
Mindy comes to Qserve with more than 15 years of experience in medical device international Regulatory Affairs. During that time, Mindy worked for a private medical device manufacturer and two Notified Bodies, providing expertise in European, Canadian and Australian medical device regulations and medical device quality management systems.
As the Senior Director of International Regulatory Compliance at TransMedics, a manufacturer of portable, ex-vivo perfusion and assessment donor organ transplantation devices, Mindy developed and implemented regulatory strategies, and worked closely with regulatory authorities and the executive team to support existing commercial products, new product development and clinical investigations for markets outside of the USA.
At SGS, Mindy was the Vice President of Health Care in North America, responsible for the management of the medical device, healthcare and pharmaceutical and cosmetic auditing certification and medical device CE certification business. At DEKRA (formally KEMA Quality), Mindy served as the global Certification Manager and Senior Project Manager where she worked closely with the Dutch Competent Authority, Notified Bodies, Project Managers, and medical device manufacturers. Mindy has extensive experience auditing and performing technical reviews of both high-risk and low-risk medical devices, having conducted over 200 design dossier/technical file review and over 500 audits. She also conducted extensive training in regulations and future developments. In her career at the Notified Body, she was technical expert and reviewer for labeling, risk management, packaging, shelf life, and sterilization aspects.