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Similar Devices in State of the Art

Originally Published May 4, 2023
By Priscilla S. Monarca, M.P.H.

This article defines similar devices and best practices for similar device data included in state of the art evaluations and CERs under EU regulations. Get the article here.

The Road to IVDR Implementation

Originally Published March 20, 2023
By Sarah McLeod, M.S.

Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. This article takes a closer look at the revised implementation timeline and potential impacts on certification. Get the article here.

Medical Device Claims and Clinical Evaluation Under the EU MDR

Originally published February 13, 2023
By Miriam Sharif-Murray, M.S.

A closer look at the requirements for medical device claims and how they impact the clinical evaluation process, subsequent Clinical Evaluation Report and eventual conformity to medical device regulations. Get the article here.

Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective Part III: The Final Clinical Literature Evaluation Report

By Richard Conforti, M.S.
Originally published August 15, 2016
This is the third article in a 3-part series on the 2014 Chinese Food and Drug Administration(CFDA), providing an update on their medical device regulations. The first article discussed which devices can be used to support your submission to the CFDA. The second article addressed the changes to selecting clinical literature. This article will describe the final clinical literature report.
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