Medical device firms should implement design level hazard analysis as part of the design control program, but ISO 14971:2006 ushered in the expectation that risk management is a life-cycle commitment. Medical device development teams need to understand how to integrate hazard analysis and risk assessment into verification and validation planning. Risk assessment now plays a greater role in FDA submissions, particularly for software controlled devices.

Management must have effective tools for life cycle risk management that integrate all the factors at play in Risk Management for medical devices. This can include process level risk assessment, hazard assessments when considering the recall of a product, prioritization of CAPAs and feedback from customer use such as from complaints and MDRs.

Paladin Medical will guide you through:

  • Design hazard analysis
  • User risk analysis
  • Process FMEA
  • Fault-tree analysis
  • Complaint analysis and trending
  • Corrective and preventative actions (CAPA)
  • Management reviews and quality audits
  • Risk Analysis supports
  • New product development planning (Design Controls)
  • New product submissions
  • Implementation in conformance with:
    • FDA CFR 820 for QS
    • ISO 13485:2003
    • ISO 14971:2006