|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.|
|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|