Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)
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|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.|
|Personnel in design, construction, purchasing, production, engineering, QA and QC who will be involved in Risk Management.|
|Lectures and workshops.
Workshops may be performed using your own products and processes.
No of participants
|Qualification test||Written test may be included – if desired|
Contact us if you have questions or if you would like us to send an offer!