Risk Management – Medical Devices

ISO 14971

Course length
2 days

Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)

Fakta om kursen


Background Risk Management – i.e. the planning, analysis and assessment of risks related to a medical device is a requirement for premarket product approval in for example EU USA and Canada.

ISO 14971 replaces EN 1441 as harmonized standard for risk analysis within EU.

Scope Through lectures and practical work with Risk Management of a product allow for thorough understanding and skills. Each participant will learn how to plan, lead, perform and report the results of Risk management activities.
Intended for


Personnel in design, construction, purchasing, production, engineering, QA and QC who will be involved in Risk Management.








  • Risk Management – ISO 14971
  • Risk Management Planning including criteria for acceptable risk
  • Risk Analysis, Risk Assessment (FMEA, FTA) and Risk Control
  • Risk Management File
  • Risk Management Review
  • Corrective and preventive actions


Lectures and workshops.
Workshops may be performed using your own products and processes.

No of participants

Maximum 16
Qualification test Written test may be included – if desired
Documentation Course file


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