Originally published February 13, 2018
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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. Read more
Clinical Literature Evaluations to Support Medical Device Marketing
By Roz Sweeney, Ph.D. Nerac Analyst,
Comprehensive evaluations of the clinical and technical literature serve a variety of purposes for medical device companies.
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EU Regulatory Compliance
Issue: The client, a major cardiovascular stent company, wanted to ensure proactively that their intra-aortic balloon pump (IABP) catheters would comply with new EU regulations. Read more.