With this webinar, we hope to show industry professionals just how this Special Controls trend has picked up pace, and what it means now and going forward.
LEXINGTON, Mass. (PRWEB) November 20, 2017
Cognition Corporation, a software company specializing in medical device compliance and commercialization, is hosting an end-of-year webinar focusing on Class II Special Controls device classifications.
The webinar on December 13 will discuss recent trends in Special Controls classifications, the ways in which those trends impact medical device product development, and practical examples in the industry today.
Class II Special Controls classifications offer explicit guidance for certain types of Class II devices based upon safety concerns. When a device falls under this classification, FDA looks for “reasonable assurance of safety and effectiveness” when insufficient evidence is available to establish general controls.
“It’s very interesting, what we’re seeing when it comes to these types of classifications,” says Larry Nicholson, Director of Business Development at Cognition. Nicholson, who will lead the webinar, has conducted extensive research and analysis on the world of Class II Special Controls.
Among his findings, Nicholson has determined that the frequency of these classifications has increased over 240 percent in the last seven years alone. “Why this rise has happened so rapidly in less than a decade is intriguing, and the digging we’ve done to wrap our heads around it is worth sharing.”
This webinar is the next of a series featured by Cognition. Every month, members of the Cockpit Crew host public sessions discussing the latest trends in the medical device, pharmaceutical, and combination products industries.
“With this webinar, we hope to show industry professionals just how this Special Controls trend has picked up pace, and what it means now and going forward,” says Nicholson.
Spots are limited, so Cognition encourages everyone who is interested in attending the December 13 webinar to sign up soon. Click here to register.
Cognition Corporation, based in Lexington, Massachusetts, has offered solutions for product development compliance for more than fifteen years. Cognition’s core product, Cognition Cockpit™, is used by thousands of users worldwide to manage their product development process and meet regulatory, performance, re-use, and time-to-market goals. For more information, visit http://www.cognition.us or call (781) 271-9300.