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.

About Risk Management - ISO 14971:2019

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

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