RRisk Assessment & Management

ISO 14971 is an international standard for risk management of medical devices. It is recognized by the US Food and Drug Administration (FDA), European authorities, Health Canada, the Australia Therapeutic Goods Administration and other regulators as the "de facto" standard for risk management of medical devices. ISO 14971 is an integral part of a quality system and should be incorporated into the life cycle process of medical devices.

Why choose Technimates for medical device risk management:

  • We specialize in quality assurance for medical device and IVD companies.
  • Our consulting team has implemented hundreds of FDA QSR and ISO 13485 quality systems at medical device companies making a wide range of Class I, II and III devices.
  • Our experienced team of consultants is skilled at identifying and reducing risk in all types of devices and processes.
  • We have extensive experience integrating EN ISO 14971 into existing ISO 13485 and FDA GMP quality management systems.

Our risk management team can help with:

  • ISO 14971
  • ICH Q8
  • Hazard Analysis / Hazard and Operability Study
  • Failure Mode and Effects Analysis (FMEA)
  • Fault Tree Analysis (FTA)
  • Hazard Analysis Critical Control Points (HACCP)
  • Control Plans
  • Action Items
  • Risk Assessment of Customer Complaint
  • Risk Acceptance Criteria