Risk Management has been a recurring theme over the last 20 years and the MedTech sector has matured. We have now reached a stage where risk management has become a central mechanism for systems operating in this industry sector.
Risk Management is a fundamental step for medical device manufacturers to demonstrate compliance to the EU Medical Device Regulations, ensuring the safety of patients and users. Since the introduction of the ISO14971:2012 there has been a lot of confusion surrounding the implementation of the new standards, by medical device manufacturers.
This course will explore the requirements of ISO14971:2012, also touching upon what documentation is required.
Join this course to find out more about:
- The methodology in design and product management
- What considerations should be taken when running this process?
- How this vital information should be used, along with other critical elements
This course is aimed at leading Risk Management Teams, Quality Regulators, Senior Managers and those that want to develop their knowledge in Risk Management.
To find out more information or register your place, please click here.