DNV GL Česká republika

Risk Management according to 14971:2012

Risk management training DNV GL

Basic introduction to the requirements on the Risk Management according to 14971:2012. 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 the risks related to a medical device is a requirement for premarket product approval in for example EU USA and Canada.

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

Time:


6th Semptember 2018


Location:


DNV GL Busimess Assurance Czech Republic s.r.o., Thákurova 4, 1 60 00 Praque 6/ Hotel Diplomat

Price:


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

Registration:


You can register on e-mail address: sylva.hefnerova@dnvgl.com or +420 603 575 839

Background


Risk Management - i.e. the planning, analysis and assessment of the risks related to a medical device is a requirement for premarket product approval in for example EU USA and Canada.

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

Time:


6th Semptember 2018


Location:


DNV GL Busimess Assurance Czech Republic s.r.o., Thákurova 4, 1 60 00 Praque 6/ Hotel Diplomat

Price:


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

Registration:


You can register on e-mail address: sylva.hefnerova@dnvgl.com or +420 603 575 839

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