Medical Device Consulting

The Medical Device Regulations outline the requirements for registration and sale of medical devices in Canada. DSA Consultants offers a range of medical device consulting and regulatory solutions to help our clients comply with the requirements of the Medical Device Regulations and comply with the expectations of the Health Products and Food Branch Inspectorate.

With the onset of Health Canada Inspections of Medical Device Establishments, many companies, even large multinationals, are caught off guard at the findings of the Inspectorate. Some firms, even those who have been successfully audited by Health Canada for drug GMP compliance, have been cited as being not compliant with the medical device regulations. It is more crucial than ever that medical device establishments subject themselves to an assessment to ensure compliance.

Our Medical Device Regulatory Solutions includes:

• Regulatory Submissions and Labelling Compliance
• Establishment Licences
• HPFBI Inspections
• Complaints and Mandatory Problem Reporting
• Mapping & Validation (including Cold Chain Packaging)
• Documentation & Procedures
• GMP Training

Contact us to find out more about the Medical Device Regulatory Solutions and a DSA Regulatory Affairs Specialist can assist you with your compliance needs. Please click here to receive a free copy of our white paper on marketing a therapeutic product in Canada.