DNV GL Danmark

Risk Management - ISO 14971:2019

Risk Management ISO 14971:2012

This course will give an overview of the standard, the process and the tools. With expectations from Notified Bodies and authorities also being discussed. The process interface and the resource needs will be part of the course along side a workshop on risk analysis. The ISO/TR 24971 will also be covered.

About Risk Management - ISO 14971:2019

Risk management was requested when the MDD 93/42/EEC was released and is one of the big processes through the coming MDR 2017/745.  Over the years there have been updates and changes in the standard as well as in the interpretation and industry practice. 

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).

Program:

Introduction to the ISO 14971

• Background and regulatory requests

• The risk management process

- Risk Management Plan (RMP)

- Acceptance criteria

- Risk Analysis

- Risk Management Report

• Process interfaces and organization requirements

Risk analysis

• What kind of risk analysis and technique?

• Work shop RMP and risk analysis

• Presentation work shop

Discussion and questions

Venue:

The training is held as online training.

Date:

20 October 2020.

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Register for the training class here

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Hvornår:

20. oktober 2020

Add to calendar 2020/10/20 09:00 2020/10/20 18:00 Risk Management - ISO 14971:2019 This course will give an overview of the standard, the process and the tools. With expectations from Notified Bodies and authorities also being discussed. The process interface and the resource needs will be part of the course along side a workshop on risk analysis. The ISO/TR 24971 will also be covered.
https://www.dnvgl.dk/training/risk-management-iso-14971-2019-156034
This only adds the event to your calendar, please remember to register for this event.
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Varighed:

The training is held online. 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 14971:2019

Risk management was requested when the MDD 93/42/EEC was released and is one of the big processes through the coming MDR 2017/745.  Over the years there have been updates and changes in the standard as well as in the interpretation and industry practice. 

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).

Program:

Introduction to the ISO 14971

• Background and regulatory requests

• The risk management process

- Risk Management Plan (RMP)

- Acceptance criteria

- Risk Analysis

- Risk Management Report

• Process interfaces and organization requirements

Risk analysis

• What kind of risk analysis and technique?

• Work shop RMP and risk analysis

• Presentation work shop

Discussion and questions

Venue:

The training is held as online training.

Date:

20 October 2020.

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