Risk Management for Medical Devices


Course Overview

Our two day real-time instructor-led ISO 14971:2019 Risk Management training course focuses on the application of various risk management tools to meet the requirements of the harmonised standard ISO 14971:2019. 

ISO 13485:2016 requires medical device manufactures to implement a Quality Management System that has a greater emphasis on risk. This course for medical device manufactures has been developed to meet this more rigorous focus on risk management.

Our expert tutors will provide you with an in-depth understanding of ISO 14971:2019 in addition to comparing ISO 14971:2019 with the requirements of the EU Medical Device Regulation (MDR) 2017/745. 

Our virtual courses bring you, our expert tutors and fellow delegates together on a web based classroom where you can fully engage in group activities, ask questions and share materials as if you were in a real classroom. All you need to be able to attend is access to a microphone and Google Chrome. 

Course Content 

▪    Introduction to ISO 14971:2019

▪    Regulation and the Z-Annexes

▪    The procedure and plan

▪    FMEAs and fault trees

▪    Application to ISO 13485

Understand the relationship with other standards: 

▪   The 60601/61010 series

▪   Usability (EN 62366)

▪   Biocompatibility (ISO 10993)

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? 

▪    PDF training course notes, slides and handouts

▪    PDF ISO 14971 Risk Management training course certificate 

Book your place →


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Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk


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