Qualifications

PASB’s principals hold the Regulatory Affairs Certificate (RAC), the leading credential for regulatory professionals in the medical device sector. RAC holders must have sufficient experience and pass a rigorous exam testing their knowledge in global medical device regulations and regulatory strategy.

We are certified as lead auditors in ISO 13485, the international standard for medical device quality management systems recognized by regulators globally, including in the USA, Canada, and the European Union.

The Medical Device Single Audit Program allows companies to have a quality management system that is recognized by regulators in participating countries (currently the USA, Canada, Japan, Brazil, and Australia) and eliminates the need for separate inspections by their regulatory agencies. PASB has received formal training from BSI in the application of MDSAP and can advise on all aspects of implementing an MDSAP-compliant QMS.

PASB is managed by professional engineers with degrees in mechanical and chemical engineering. PASB holds a permit to practice professional engineering in the province of Newfoundland & Labrador from PEGNL, the provincial engineering licensing body. We follow a code of ethics encompassing tenets that include protection of the public, competence and diligence, being faithful agents, continuing competency and professionalism.