Medical Device Regulation (MDR) General Overview (EU) 2017/745
Risk Management for Medical Devices
Online Overview of Risk Management & ISO 14971:2019
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We have partnered with Comply Guru, an expert leader in online training to make our Risk course available as an eLearning course.
This online course will offer an interactive, comprehensive overview of risk management to medical devices based on ISO 14971:2019 which has just been released & includes an overview of the key changes.
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. The future regulation builds on the requirements of risk management.
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.
You’ll be assessed through one online multiple choice exam. In order to successfully complete the course, you will need to obtain a grade of 70% or higher.
Successful completion will entitle you to receive a certificate of completion.
After the course is completed, you can still go back in during your access period to review the course content as many times as you like.
Who should attend?
▪ Quality Assurance professionals
▪ Quality Engineers
▪ Research and Design Engineers
▪ Internal Auditors
▪ Quality Managers
▪ Manufacturing Engineers
▪ Regulatory professionals