Technical Documentation: Requirements under MDR
The new Medical Device Regulation (MDR) has arrived. The Regulations contain enhanced requirements for Technical Documentation – often referred to as the Technical File – for each medical device or family and requires that the information be presented in a clear, organized, readily searchable and unequivocal way.
The transition period of three years may seem a long time, but the earlier you start strategically planning you product portfolio and initiate a review of the Technical Documentation requirements, the improved chance of successfully meeting the MDR.
The webinar will cover:
- Overview of Technical Documentation Requirements
- New requirements
- Clinical investigations and equivalence
This webinar will help you to consider what actions you need to start now to be prepared for the change in requirements; the webinar will allow you to start planning how to meet the new requirements in this area.
Dr. Amie Smirthwaite is Clinical Oversight and Training Lead at BSI, where she has previously worked as a Product Technical Specialist and Scheme Manager for the Orthopaedic and Dental team. Amie has nearly 20 years’ postdoctoral experience, covering new product development, production, quality system management and regulatory affairs within the medical devices industry.
Her qualifications include a BEng in Biomedical Engineering, a BSc in Mathematics and a PhD in Biomedical Engineering.