HPFBI 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 now offers HPFBI 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 HPFBI 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 HPFBI audit and follow through to acting as your management representative during the audit itself.

To find out more about marketing a therapeutic product in Canada, please click here to receive a copy of our free white paper. To find out more about using our Regulatory Affairs Services for Medical Device, please contact us for more information.