Risk Management to Medical Devices 

This in-depth overview focuses on the application of various risk management tools to meet the requirements of the harmonised standard BS EN ISO 14971:2019.  

The current law, medical devices directive 93/42/EC requires implementation of the state of the art, implementation of the harmonised standard provides presumption of conformity. BS EN 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.


This course is fully certified by Comply Guru™ & Meddev Solutions.

In order to successfully complete the course, you will need to obtain a grade of 70% or higher in the final multiple choice examination. Successful completion will entitle you to receive a certificate of completion.

Who should attend?

▪Quality Assurance professionals

▪Quality Engineers

▪Research and Design Engineers

▪Internal Auditors

▪Quality Managers

▪Manufacturing Engineers

▪Regulatory professionals


Meddev Solutions Ltd

River House, Home Avenue 

Newry BT34 2DL

Email: info@meddevsolutions.co.uk


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