Compliance Support

Complementing our engineering services PASB offers trusted, competent regulatory compliance consulting in a number of key areas. 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:

  • 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
  • Supplier evaluation and quality agreement development
  • FDA and EU MDD/IVDD 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. 


Machine Safety

In Canada, machine safety is regulated by provincial Occupational Health and Safety legislation. End users are ultimately responsible for ensuring that their workers are adequately protected from potential machinery hazards.

As experienced engineers with in-depth knowledge of automation and machine design principles, we can assess your equipment for conformance with key safety standards recognized by provincial authorities.  We can support your machine safety requirements in the following ways:

  • Risk assessment
  • Safeguarding evaluation in accordance with CSA Z432
  • Research and recommendation of risk reduction measures


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.