The Medical Devices Regulations outline the requirements for registration and sale of medical devices in Canada. DSA Consultants offers a range of medical device consulting solutions to help our clients comply with the requirements of the Medical Devices Regulations and comply with the expectations of the Health Canada.
With the onset of Health Canada Inspections of Medical Device Establishments, many companies, even large multinationals, are caught off guard at the audit findings from Health Canada. Some firms, even those who have been successfully audited by Health Canada for drug GMP compliance, have been cited as being non-compliant with the medical devices regulations. It is more crucial than ever that medical device establishments subject themselves to an assessment to ensure compliance.
Our Medical Device Regulatory Solutions include:
- Regulatory Submissions
- Establishment Licences
- Health Canada Inspections
- Complaints and Mandatory Problem Reporting
- Mapping & Validation
- MDEL Attestations