ISO 14971

Course length
2 days

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

Facts

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.
Contents	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
Program	Lectures and workshops. Workshops may be performed using your own products and processes.
No of participants	Maximum 16 persons
Qualification test	Written test may be included – if desired
Documentation	Course file

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