Risk Management for Medical Devices

VIRTUAL CLASSROOMS

Course Overview

This course has been designed by our industry leading experts to help you understand the importance and purpose that ISO 14971 has on the decision-making process when manufacturing medical devices.

 

It explores the relationships between ISO 14971 and ISO 13485, MDR 2017/745, IVDR 2017/746 and 21 CFR part 820 to provide you with an understanding of how ISO 14971:2019 can improve your business and risk management efforts.

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 

- AFAP and ALARP

 

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