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 met with the owners of the company who gave us a brief tour of their facility. We reviewed their operations and inventory against their Medical Devices Establish License and several non-compliances were noted. DSA also conducted an audit of the firms Standard Operating Procedures and found several gaps which needed to be addressed.
Prior to the audit, DSA managed several amendments to the firm’s Medical Devices Establishment License to help bring company operations into compliance. We also drafted updates to all of the firm’s MDEL attestation procedures.
While not everything could be fixed by the firm prior to the audit (ex. labeling non-compliances which are the responsibility of the manufacturer); they were in pretty good shape by the audit; resulting in only 4 observations. The firm is now actively working with its suppliers to close out the labeling observations. They were so pleased with the work we did for them; that they have referred two of their distributors to us who are now signed as clients of our firm.