Zero to ISO 13485 in 90 Days

Whether your organization designs, develops, manufactures, packages, sterilizes, and or installs and services what are regulated as medical devices or in-vitro diagnostics, or contracts these services out, throughout most of the world, you need a quality system, and for most organisations, it needs to be certified. For most medical devices in Canada, registration by a CMDCAS registrar to ISO 13485 is required now, and soon, MDSAP registration will be required.

For many medical devices in Europe, ISO 13485 registration and AIMD, MDD or IVDD certification is required now. Soon, certification to the new EU Medical Device Regulation will be required.

If you’re already certified, but not to ISO 13485:2016, or if you’re already CMDCAS registered, but need to start your MDSAP program, you’ve come to the right place.  If you are already certified, but your quality system documentation is out of control and or costs are beyond your budget, please contact us here.


*Clients choosing our ‘13485 Express’ service are ready for the Stage I registration assessment within as little as 90 days.