Risk Management for Medical Devices


Course Overview

Our industry leading experts have created a 2-day course to help you understand the requirements of ISO 14971 and the importance for medical device manufactures.

It explores the ISO 14971 standard clause by clause to ensure a thorough understanding of the requirements. The course also provides an understanding of how ISO 14971 aligns with the new MDR and IVDR regulations.

This course is fully interactive and offers you the chance to take part in group activities, participate in polls and share and download course materials. We are here to help you make your medical devices compliant.

Course Agenda

Module 1

- Purpose, History and Structure of ISO 14971

- Key Changes introduced by ISO 14971:2019

- Definitions and Key Terminology

- Relationship with other Standards

- Risk Management and the Product Lifecycle

Module 2

- The Risk Management Process

- The Risk Management Team and Roles 

- The Risk Management Plan and What It Contains

The Risk Management File

Module 3

Risk Analysis 

- Hazards and Hazardous Situations

- Risk Estimation, Probability, Severity and Detectability

- Risk Evaluation

Module 4

- Risk Control

- Risk Analysis and Measures

- Residual Risk and Risk Review

- Benefit Risk Analysis

- Production and Post-Production Activities

- Implementation of Risk Controls

- Risk Management Tools and Techniques 



Module 5

- Overall Residual Risk Evaluation

- Risk Management Review

- EN ISO 14971:2012 vs EN ISO 14971:2019 

- Purpose and Structure of ISO/TR 24971

- Annex Z Deviations

- Overview of Key Annexes

Date: 27 - 28 July, 2021

Location: Live online classroom

Day 1: 9:00am - 16:00pm

Day 2: 9:00am - 16:00pm

The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.

Working on a Laptop

Who should attend?

This ISO 14971 training course has great value for anyone involved in implementing or maintaining a QMS. 

▪    Quality Assurance professionals

▪    Quality Engineers

▪    Research and Design Engineers

▪    Internal Auditors

▪    Quality Managers

▪    Manufacturing Engineers

▪    Regulatory professionals

What will I receive? 

- 2 days of live online training

- Browser-based, no downloads required

- See presenters and interact with fellow attendees

- Get your questions answered!

- Download documentation and certification of completion

- 10% discount on bookings of 2 or more