DNV GL Danmark

Risk Management ISO 14971:2012 - Incl. updates on the FDIS 14971:2019 and 24971:2019

Risk Management ISO 14971:2012

Risk management was requested when the MDD (93/42/EEC) was released. The MDR (2017/745) and IVDR (2017/746) are requesting even more from the risk management process and it becomes a system now. Over the years there have been updates and changes in the standard as well as in the interpretation and industry practice. This course will give the overview of the standard, the process and the tools. Expectations from Notified Bodies will also be discussed as well as authorities’ expectations. The process interface and the resource needs will be part of the course. A workshop will give guidance on risk analysis.

About Risk Management ISO 14971:2012 

Goal:

To give a basic understanding and give some tools on how to run and benefit from the risk management process.

Who benefits:

Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.

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 or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark

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When:

Add to calendar 2020/03/17 09:00 2020/03/17 18:00 Risk Management ISO 14971:2012 - Incl. updates on the FDIS 14971:2019 and 24971:2019 Risk management was requested when the MDD (93/42/EEC) was released. The MDR (2017/745) and IVDR (2017/746) are requesting even more from the risk management process and it becomes a system now. Over the years there have been updates and changes in the standard as well as in the interpretation and industry practice. This course will give the overview of the standard, the process and the tools. Expectations from Notified Bodies will also be discussed as well as authorities’ expectations. The process interface and the resource needs will be part of the course. A workshop will give guidance on risk analysis.
https://www.dnvgl.dk/training/risk-management-iso-14971-2012-incl-updates-on-the-fdis-14971-2019-and-24971-2019-156034
This only adds the event to your calendar, please remember to register for this event.
Copenhagen, Denmark false YYYY/MM/DD akeGphYOczrmtQTfhmEQ22349

Available dates and venues

Varighed:

Duration: 1 day

Pris:

Course fee: DKK 6.800,- (ex. VAT). Course material and certificate of participation is included in the price.

Yderligere information:

You can find our cancellation policy, terms & conditions and practical information about the course here: www.dnvgl.dk/betingelser

About Risk Management ISO 14971:2012 

Goal:

To give a basic understanding and give some tools on how to run and benefit from the risk management process.

Who benefits:

Management, design and development engineers, QA/RA specialists, risk managers, customer support/service, clinical support, marketing, contract manufacturer and component manufacturer as applicable.

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 or Swedish (depending on the participants).

Venue:

The training is held in the area of Copenhagen, Denmark

Available dates and venues

DATES VENUE REGISTER BY COURSE FEE ADDITIONAL INFORMATION
DATES
17. marts 2020
VENUE
Copenhagen, Denmark
REGISTER BY
COURSE FEE
ADDITIONAL INFORMATION
DATES
20. oktober 2020
VENUE
Copenhagen, Denmark
REGISTER BY
COURSE FEE
ADDITIONAL INFORMATION

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