Benefits of ISO 14971 Risk Management Certification

   The first certification program developed based on the ISO 14971:2007 standard

   Provide independent third-party confirmation and objective evidence of compliance

  Suppliers can gain a competitive advantage and be recognized by manufacturers and regulatory bodies

   Demonstrate that the risk procedures for electrical medical devices comply with ISO13485:2003 and IEC 60601-1 standards

  Establish robust risk management and increase the speed of listing

   Widely used by FDA, Japan PAL, Health Canada, Australia and other regulatory bodies as a regulatory process for new product development

  A process-focused approach enables manufacturers to improve internal audit and control procedures