Why is it important to establish state of the art during the clinical evaluation?

At the 2018 MedTech Summit, on June 11 – 15 in Brussels, Belgium, Laurie Mitchell, our President, will be giving a presentation with Evidence Partners entitled: State of the Art: Best Practices and Literature Review Using DistillerSR. In this blog post, we will give you insight into some of that content, but to see the whole topic, we recommend you register for the conference, or check back on our blog in late June to download our full whitepaper. Below is a sneak peak at this topic.

The large number of mentions of state of the art throughout MEDDEV 2.7/1 rev 4 provide not only a comprehensive description of the importance, purpose, and role of establishing the state of the art, but also inform on how to incorporate this analysis into the clinical evaluation. The image below summarizes several core roles of this analysis.

 

Establishing and describing state of the art is not an isolated task, but is central to the entire clinical evaluation. Defining the current, accepted best treatment options, and describing the risks and benefits of these options, provides essential information for multiple aspects of the clinical evaluation. Thus, establishing state of the art yields information that is essential for determining if the safety and performance of a device is compatible with current standards (in comparison to available treatment options). In other words, state of the art establishes a reference standard that is used throughout the clinical evaluation.


If you want to find out more about State of the Art according in MEDDEV 2.7/1 rev 4, you can come see our presentation at the 2018 MedTech Summit June 11 – 15 in Brussels, Belgium (register here), or check back on our blog after this date to download our full whitepaper.

Tags: , ,

Generis American Medical Device Summit

October 24-25, 2018

The Westin Lombard Yorktown Center
Lombard, IL 60148

 

Schedule a meeting with our President, Laurie and our CEO, Lalitha

Haven’t registered yet? Contact us to get your 65% discount code!