Risk Management according to 14971:2019 Online Seminar (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, construction, 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) committee and was also part of the international PMS task force.
Language:
Course material is in English, presentation in English
Place:
Online Seminar
Is needed: internet connection, laptop or PC, google chrome internet browser
Note: Slovak 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, construction, 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) committee and was also part of the international PMS task force.
Language:
Course material is in English, presentation in English
Place:
Online Seminar
Is needed: internet connection, laptop or PC, google chrome internet browser
Note: Slovak VAT will be applied for all participants.