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