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 Health Canada, U.S. FDA and international classification and preparation of regulatory submissions for registration of medical device.
We provide the following medical devices regulatory registration and establishment licensing application 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