Risk Management according to 14971:2019 (in English)
Basic introduction to the requirements on the Risk Management according to ISO 14971:2019/TR 24971:2019. The course will also give tools and practical examples (workshop) on how to comply with the requirements.
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, costruction, purchasing, production, engineering, QA and QC who will be involved in Risk Management.
Course leader:
Anette Sjögren, PREVENTIA AB. Anette is a member of the Swedish (TK355 - ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) commitee and was also part of the international PMS task force.
Language:
Course material is in English, presentation in English
Note: Czech VAT will be applied for all participants.
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, costruction, purchasing, production, engineering, QA and QC who will be involved in Risk Management.
Course leader:
Anette Sjögren, PREVENTIA AB. Anette is a member of the Swedish (TK355 - ISO 13485, ISO 14971 and IEC 62366) and the international technical (TC210) commitee and was also part of the international PMS task force.
Language:
Course material is in English, presentation in English
Note: Czech VAT will be applied for all participants.