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
  • Product Design History File (DHF) compilation
  • 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. 


CE Marking

In order for certain products to be marketed in the European Economic Area (EEA) they must bear CE (European Conformity) marking, which demonstrates that the product satisfies the applicable EU Directive for that product class.  In this sense, CE marking can be considered a product "passport" allowing the product to be sold in the entire EEA single market.

EU Directives are legislated sets of rules specifying the areas of compliance required for certain product groups. These compliance rules are formally termed "essential requirements" in the Directives. 

There are many Directives covering industrial and consumer product groups such as medical devices, machinery, pressure equipment and toys.  For a current listing of all CE product group Directives see here.

The CE marking process involves six steps: 

  1. Identify the applicable directive(s) and harmonized standard.
  2. Verify the product-specific requirements.
  3. Identify whether an independent conformity assessment (by a notified body) is necessary.
  4. Test the product and check its conformity.
  5. Prepare and retain the required technical documentation.
  6. Affix the CE marking and draw up the EU Declaration of Conformity 

PASB, together with our partner Obelis, are pleased to assist organizations requiring specialized support at any stage of this process.