Atinza can support clients in full services
Medical device consulting
- Label Reviews and Classification of Products, Class I to IV
- Prepare and Submit Applications for Class II, III or IV
- Obtain and maintain Medical Device Establishment Licenses
- Host Health Canada Medical Device Establishment Licence (MDEL) Inspections
Post market surveillance
to improve monitoring and reduce the recurrence of incidents related to medical devices in Canada
- Health Canada, along with its international partners in the Global Harmonization Task Force (GHTF), has developed agreements and documents to promote a harmonized approach to medical device regulation around the world.
- The person required to report mandatory problem reports to Health Canada, in accordance with Medical Devices Regulations concerning mandatory problem reporting (sections 59 through 61.1(2)).
- Atinza can report incidents to Health Canada on behalf of clients.
Our supports also cover
other matters of post-market surveillance
- Medical device market tracking, user information development and improvement post incident
- Risk management via preventive action through design and manufacture of device
- Assisting with implementation of corrective actions following an incident occurrence
- Guidance services
- Timely response to inquiries of Health Canada on behalf of the clients
- Communicate with suppliers and customers of clients to coordinate all correspondence and fulfill tractability requirements.