ISO 14971 Risk management certification program

Benefits to the BSI ISO 14971 Risk management certification program:

  • First certification program developed to ISO 14971:2007 standard
  • Provides independent 3rd party validation and objective evidence of compliance
  • Suppliers can gain a competitive advantage which is recognized by manufacturers and regulatory authorities
  • Demonstrates that risk process conforms to ISO 13485:2003 and IEC 60601-1 for electromedical devices
  • Increase speed-to-market with the establishment of robust risk
  • High profile process with FDA, Japan PAL, Health Canada, Australia and other regulatory agencies management processes for new product development
  • Process-centered approach can enable manufacturers to improve internal auditing and control processes
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