A Canadian Medical Device License (MDL) is required for companies selling Class II – IV medical devices in Canada. For manufacturers, importers and distributors selling medical devices into the Canadian market place, navigating regulatory requirements can be challenging. Our professionals bring real-world experience to make your Canadian, U.S. FDA and international medical devices regulatory registration submissions seamless.
We provide the following Medical Devices Regulatory Registration Services.
- Regulatory Audit Preparation
- Quality System Implementation & Maintenance
- ISO 13485:2016
- FDA CFR 21 Part 820 – Quality System Regulation
- MDSAP (Medical Device Single Audit Program)
- MDEL (Medical Device Establishment Licensing)
- HEALTH CANADA – Medical Device Licencing
- FDA 510(K) Submissions