Risk management training ISO 14971- Risk Management System and ISO 14971 – 2 Days

What will you learn during this Risk management training ISO 14971 class:

  • Presentation of the background of the technical documentation and its content
  • Introduction to ISO 14971: objectives and review of the different steps of the risk management process
  • Risk Management: GHTF guidance, Human Factor, Introduction to the different tools to use during risk management activities

Our training sessions include presentation, exercise, case study, workshop, handouts, reference documentation or use of relevant database when applicable. The instructors are experienced and subject matter experts.

Here is the catalog of training we are currently proposing:

  • FDA cGMP Quality system conformity to CFR21-Part820 – 2 Days
  • FDA 510k submission – 2 Days
  • European Regulation of Medical Devices – 1 Day
  • ISO 13485 – 2 Days
  • ISO 9001 – 1 Day
  • Risk Management System and ISO 14971 – 2 Days
  • Software Development Life Cycle – 2 Day
  • Internal Audit and Supplier Audit – 2 Days

If you wish to participate in one of these training please contact us for a preliminary discussion.