UC San Diego Innovation Calendar
Did you know that the term “state of the art” appears approximately 39 times in MEDDEV 2.7/1 rev. 4 (compared to just four times in the previous version of the regulations)?
Establishing and defining state of the art for a medical device is no longer an isolated task – it supports the entire Clinical Evaluation Report (CER). Multiple sections of the MEDDEV 2.7/1 rev 4 compliant CER need to be supported by state of the art data, including safety and performance, risk management, and equivalence.
As we approach the May 2020 deadline for the new EU MDR, this webinar will discuss the best practices and tools that can be adopted right now to produce fully compliant state of the art literature reviews.
Join this webinar to learn:
- Key components of an effective state of the art description – what the notified bodies expect to see
- Common points of failure in state of the art literature reviews
- Sound methods and expert tips for completing an effective literature search
- Best practices to efficiently produce and maintain a fully compliant and audit-ready clinical background/state of the art description using DistillerSR
Keywords: Clinical Evaluation Report, EU MDR, Literature Reviews, Medical Device Compliance
Peter O’Blenis, President, Evidence Partners
Laurie Mitchell, President, Criterion Edge