Audits

Medical Device Single Audit Program (MDSAP) Update

By |March 30th, 2016|

The Medical Device Single Audit Program (MDSAP) Pilot will conclude December 31, 2016.

MDSAP will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program, even in situations when a manufacturer intends to sell only in Canada. MDSAP will be the sole mechanism for demonstrating compliance with the quality management system (QMS) requirements of the Medical Device Regulations.

The […]

Handling Medical Devices Establishment License Audit

By |February 24th, 2016|

DSA Consultants was recently hired by a local Mississauga firm to handle their Medical Devices Establishment License Audit with Health Canada. The firm is currently licensed as an Importer of Medical Devices into Canada. They were referred to DSA by one of our existing clients.

The first step of the project was to conduct an onsite assessment. We […]

DSA Travels to Mexico

By |February 18th, 2016|

Recently, one of our Senior Quality Consultants was tasked with an audit of a contract manufacturing site in Mexico.

The purpose of the audit was to help prepare the firm for an eventual audit by Health Canada. Our Senior Quality Consultant spent 5 days at the audit site reviewing master production records, stability, validation and other […]