|
|
Xeridiem is:
Certified to or complies with the following:
- ISO 13485:2003, Medical Devices – Quality management systems – Requirements for regulatory purposes
- Code of Federal Regulations (CFR) 21 Part 820, as amended, The Quality System Regulation for Medical Devices (QSR), 07 OCT 1996
- Canadian Medical Device Regulation (CMDR), SOR98/282
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD), as amended
- ISO 14971:2007, Medical Devices – Application of Risk Management to Medical Devices
|