SvenskaISO 14971
Course length
2 days
Facts
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
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Personnel in design, construction, purchasing, production, engineering, QA and QC who will be involved in Risk Management. |
| Contents
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| Program
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Lectures and workshops. Workshops may be performed using your own products and processes. |
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No of participants |
Maximum 16 |
| Qualification test | Written test may be included – if desired |
| Documentation | Course file |
Contact us if you have questions or if you would like us to send an offer!