ANDRE KINDSVATER, PEng SENIOR SOFTWARE, QUALITY AND REGULATORY ASSOCIATE

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:

  • Software life cycle processes in accordance with international standards and FDA guidelines
  • Obtaining and maintaining quality system certification to ISO 13485/MDD Annex II, and US 21 CFR 820/803/806
  • Software-based quality management system validation in accordance with US and European requirements
  • Compliance with European, US and Canadian medical device regulatory requirements
  • Generation of risk management files in accordance with ISO 14971
  • Development of 510(k)s for FDA Class II devices to gain entry to the US market
  • Labelling reviews for European and US markets
  • European and US post-market surveillance requirements compliance