Medical device Compliance

Complementing our engineering services, PASB offers trusted, competent medical device regulatory compliance consulting. Our personnel will work closely with you to find the most efficient regulatory pathway for your product or project.


Medical Device Quality Assurance & Regulatory Affairs

Medical device manufacturers must navigate many complex region-specific regulatory systems to bring their products to market. We work with organizations ranging from medtech start-up firms to global medical device manufacturers to ensure they meet applicable quality and regulatory requirements. We are formally trained in ISO 13485:2016 auditing through Exemplar Global and have practical experience in product design and manufacturing. Through our partners we have access to global expertise and resources in the medical device sector.  The areas we support include:

  • Regulatory strategy development
  • ISO 13485-compliant Quality Management System (QMS) development, auditing, and guidance
  • Product and establishment registration/licencing with Health Canada
  • Design controls
  • Risk management in accordance with ISO 14971
  • EU MDR compliance

We are well versed in the new EU Medical Device Regulation (MDR), which is in full effect in May 2020 and can provide compliance support for all classes of medical devices under this new regime.