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Medical device regulations require medtech companies to have specific quality system elements in place to legally market their products. PASB is highly experienced in ISO 13485, the international standard for medical device quality management systems which is recognized by the FDA, Health Canada, and European regulators.

We’re also trained in the country-specific quality system elements regulators will look for in addition to ISO 13485 requirements, particularly for companies that are participating in the Medical Device Single Audit Program (MDSAP). MDSAP is optional for most participating countries but is a requirement when entering the Canadian market for all device risk classes higher than Class I.

Increasingly, medtech companies of all sizes are turning to electronic quality management system (eQMS) cloud solutions, which reduce the paperwork burden and opportunities for error, while helping remote and/or dispersed teams follow and manage processes efficiently. 

Regardless of the type of QMS chosen, it’s critical that an organization implement a right-sized, scalable solution that works in concert with, and not in conflict with, your development and operational activities.

As certified auditors in ISO 13485, PASB can provide full QMS support to medtech companies of all sizes. Examples include:

  • Developing a full or partial QMS that efficiently maps your organizational processes while meeting regulatory requirements
  • Performing a gap analysis on existing quality systems to ensure all regulatory requirements are met, including MDSAP.
  • Supporting internal QMS audits
  • Guidance in selecting and implementing an eQMS solution
  • ISO 13485 certification support
  • Supplier qualification and audits
  • Customized training
  • Acting as your outsourced quality assurance staff who can maintain robust QMS records for inspection readiness and regulatory submissions.