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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The Young and the Restless: Scientists & Engineers Connecting across Disciplines

By Ben Bahavar Ph.D., Nerac Analyst,
Originally Published: September 15th, 2014.
A recent webinar announcement by the American Chemical Society (ACS) brought attention to a grassroots endeavor by the Network of Early-Career Sustainable Scientist and Engineers (NESSE) and how they are working to build a community of confident and able early-career sustainable scientists.
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Updating Technical Files – Is Your Company Ready for a Notified Body Audit?

by Ron Sills, M.S., Nerac Analyst
Originally published September 10, 2014

Join Nerac analyst Ron Sills in this free, interactive webinar providing an overview of how to create and maintain a Technical File that is compliant and ready for a Notified Body audit; from best practices in document choice and preparation to understanding the critical pieces of your Technical File update.