The international standard for risk management of medical devices ISO 14971 is accepted among others by the American Food and Drug Administration (FDA), the European authorities, health Canada and the Australian health authority. The EN 14971:2012 imposes with its changed foreword and the new Annex Z additional and special requirements on risk management.
PROSYSTEM as a standardization member (IEC TC62A/ISO TC210/JWG) is able to provide firsthand information that might give you a competitive advantage.
PROSYSTEM offers support for example for:

  • Implementation of a product specific risk management process
  • Implementation of DIN EN ISO 14972:2012, exclusively Annex Z
  • Risk analysis, -evaluation and –control
  • A periodic risk evaluation of medical devices on the market
  • Moderation of risk management meetings

Please feel free to contact us for further details on “risk management according to ISO 14971” or a non-binding offer.