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.