Webinar: “Avoid Rejection! Top 10 Mistakes in Medical Device Literature Reviews and How to Prevent Them”
This webinar will review common mistakes made in the literature review process and the steps needed to avoid them
- Wednesday, July 10, 2024 · 3:00 p.m. London (GMT +1:00)
Topic: “Avoid Rejection! Top 10 Mistakes in Medical Device Literature Reviews and How to Prevent Them”
Systematic literature reviews are required by regulatory agencies prove the safety and performance of medical devices, and separate reviews must be conducted at every stage of the device life cycle, including pre-market research, development, device certification, post-market surveillance.
Yet, 80% of Class IIa and Class IIb devices and almost 60% of Class III devices fail EU MDR due to nonconformant literature reviews. The main reasons fall into 3 types of issues:
1. Data issues – Volume, variety and velocity of data needed for reviews.
2. Absense of skills – Lack of expertise in regulatory affairs and data science.
3. Abiguity – Ambiguity around new device types, e.g., connected devices.
Please join Jacqueline van Druten (MICR.CIM.RD) , Clinical & Regulatory Affairs Director for CLIN-r+, as she reviews common mistakes made in the literature review process and the steps needed to avoid them.
