André Kindsvater graduated from Concordia University with a degree in Computer Science before gaining an MSc in Electrical Engineering from the University of British Columbia. Working in roles that included life science analytical chemistry, software design and validation, electrical system design and development, risk management, and quality assurance has provided him with a broad experience that he now brings to Donawa Lifescience Consulting.
Mr. Kindsvater has for over 20 years designed, implemented and maintained complete quality systems for emerging medical technology companies, meeting the requirements of the US FDA Quality System Regulation, ISO 13485:2003 and the additional requirements of Canada's Medical Device Regulations (CMDR).
Mr. Kindsvater has contributed to PMAs and submitted 510(k)s and 513(g)s for several new medical devices, and has also compiled technical files for CE marking purposes for active medical devices under the European Medical Devices Directive.
André Kindsvater can help you with: