Xeridiem is:

Certified to or complies with the following:

  • ISO 13485:2012, 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