Medical device regulation training courses (MDR)

This course is designed to give you insights into how Notified Bodies may perform a MDR QMS compliance audit, using the topics of a typical MDR audit agenda as the basis. This will enable you to optimize your auditing skills and knowledge to boost your audit capabilities, gain confidence in planning and performing an effective EU MDR QMS audit, as well as ensuring continued compliance to the EU MDR (2017/245).

Learn about the key requirements, concepts, and the overall process for CE marking under the Medical Devices Regulation (MDR).

This on-demand course is designed to increase your understanding of MDR key requirements to place your device on the market.

This course will guide you through MDR implementation. Find out best practices to implement a compliant QMS and prepare a thorough Technical Documentation package to obtain CE mark for your medical device.

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

Increase your understanding of medical device software lifecycle processes, classification rules and development activities to meet regulatory requirements.

The Medical Device Regulation (MDR) is a comprehensive set of European Union (EU) rules that govern the production, sale, and distribution of medical devices. These devices play a crucial role in diagnosing, monitoring, preventing, and treating medical conditions, ensuring they meet the highest standards of safety and performance. This short course will focus on how the MDR prioritizes safety, effectiveness, and the highest standards of public health within the EU.