The Medical Devices Regulations are due for significant update with areas such as Post Market Surveillance and Economic Operators being major areas of change. The final form of the regulations is now set and due to be voted into European Law.
The new regulations need to be considered now at all organisational levels as they will be impacting on decisions made today.
This course is designed to review critical elements of the new regulations. This training course will be an interactive in-depth 1 day session.
Course Content and Key Topics
- Economic Operator Responsibilities
- Clinical Evidence
- Technical Documentation
- Post Market Requirements
- Conformity Assessment and the Scrutiny Process
Provide attendees with the tools and insight to plan and implement their organisations strategy, for continued access to the European Market by the deadlines set in the new regulations.
To have gained a better understanding of the new regulations and the impacts the new regulations will have.
Who should attend?
Anyone wanting to advance their current understanding of how medical device regulatory affairs work in the EU and what regulators expect.
Business owners, financiers and entrepreneurs working with medical devices companies are also likely to find this course interesting.
To register or find out more information please contact Vanessa Bailey by email or by calling 0121 452 5630.