In Vitro Diagnostics – Upcoming Regulatory Developments in the U.S. and European Union: Are You Ready for the Transition?

by Roz Sweeney, Ph.D. and Donna Mitchell-Magaldi, Nerac Analysts
Originally published October 2, 2014

Join Nerac analysts Roz Sweeney and Donna Mitchell-Magaldi in this free, interactive webinar providing an overview of the upcoming regulatory changes affecting the In Vitro Diagnostics industry.
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Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond

By Ron Sills & Donna Mitchell-Magaldi, Nerac Analysts
Originally Published: September 26th, 2014
Our medical device team is at the Regulatory Affairs Professionals Society conference in Austin, TX and early reports are that the EU will be pushing hard on Notified Bodies to increase the demands on Medical Device Regulatory Affairs submissions. As a result, we feel that auditors will be much more critical in their inspection, so it is imperative that you keep your clinical literature evaluations and updates current.
We invite you to download our free white paper “Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond” to learn more about how we can help.
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