EN ISO 14971:2019/A11:2021 – Risk Management Applied to Medical Devices

EN ISO 14971:2019/A11:2021 – Risk Management Applied to Medical Devices

This seminar explores the changes introduced by the third edition of the ISO 14971 standard on medical device risk management, with a particular focus on the associated guidance, ISO TR 24971:2020.

Date

24 September,2026

Registration Deadline

17 September, 2026

Format

8-hour courses — Live streaming

Language

Italian

Price

€580 for non-clients
€435 for clients — VAT excluded

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The risk management process has a significant impact on design, manufacturing, and, more broadly, on the entire lifecycle of medical devices.

This seminar explores the changes introduced by the third edition of the ISO 14971 standard on medical device risk management, with a particular focus on the associated guidance, ISO TR 24971:2020.

Program

Introduction and scope of the standard EN ISO 14971:2019/A11:2021
Key updates in the new edition
General requirements for risk management
Overview of structure and contents
Stages of the risk management process
ISO/TR 24971: practical application and integrations
Risk management in relation to MDR (EU) 2017/745

The seminar includes

MDR Toolkit (experience, templates and tools)
Educational tutor support
Training materials
Skills assessment test
Certificate of attendance

Seminars are available for individual purchase, but they are also included in our Advanced Master, which offer more comprehensive learning paths and greater overall cost advantages.

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