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Risk Management according to 14971:2019 Online Seminar (in English)

Managing Infection Risk

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

Time:

1st October 2020. The exact timetable will be specified.

Place:

Online Seminar: „GoToTraining“ application

Is needed: internet connection, laptop or PC, google chrome internet browser

Price:

450,- € excluding VAT. DNV GL clients could apply 10% discount

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, 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

Time:

1st October 2020. The exact timetable will be specified.

Place:

Online Seminar: „GoToTraining“ application

Is needed: internet connection, laptop or PC, google chrome internet browser

Price:

450,- € excluding VAT. DNV GL clients could apply 10% discount

Note: Czech VAT will be applied for all participants.

Link to Legislation:

The Medical Devices Directive 93/42/EEC