Health Canada Inspections
The Health Canada Inspection Programme for Medical Devices started in 2003. Since that time, DSA has worked with our clients to ensure that they are prepared to handle an inspection. In response to the growing demands of the industry, DSA Consultants offers Inspection Readiness assessments to help you determine if your firm is ready to pass a Health Canada audit. DSA Consultants have worked with some multinational pharma clients who were surprised to find that they are not ready to pass a Health Canada Medical Device Audit.
During an Inspection Readiness Assessment, DSA Consultants will review and/or prepare the procedures for handling of medical devices ensuring that the procedures meet Health Canada expectation. We then address all of the areas which will be subject to review by Health Canada and ensure that all required documentation is available to be reviewed.
Because we handle so many inspections on behalf of our clients each year, we are always aware of the latest inspection trends so that we can ensure our clients are not caught off guard. We can assist you with a mock inspection to assess your readiness to pass an audit and follow through to acting as your management representative during the audit itself.
If you’ve already been scheduled for an inspection, you can hire DSA Consultants to represent you during the audit and act as your liaison with Health Canada. Whether you simply want to ensure your compliance with the MDEL requirements or you’ve been flagged for an inspection, the team of consultants at DSA can be of assistance to you.