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
▪Research and Design Engineers