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Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A 3-Part Nerac Perspective

By Richard Conforti, M.S.
Originally published August 15, 2016
This is a 3-part series of articles 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. The third article describes the final clinical literature report.
Read all three 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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Understanding CFDA Expectations Regarding Clinical Literature Evaluation for Medical Devices under Order 650: A Nerac Perspective, Part II: Selecting the Best Clinical Literature

By Richard Conforti, M.A.
Originally published June 14, 2016
This is the second article 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. In this article we will discuss the changes to selecting clinical literature.
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Notified Body Audits: Big Changes – Big Headaches

By Donna Mitchell-Magaldi, Nerac Analyst
Originally Published: December 15th, 2014
The new Regulatory Framework for medical devices currently being considered in the European Union will no doubt bring about many significant changes to manufacturers. These changes will encompass stringent Notified Body requirements and oversight coupled with increasing Notified Body authority. These changes will in turn affect your audit experience. Read More

Sample Report – Technical File Review

By Ron Sills, M.S., Nerac Analyst
Originally Published: April 7, 2014

A medical device company has requested that Nerac perform a pre-assessment audit of their debridement devices, which are a Class IIb product family, to assess compliance with the essential requirements of the Medical Devices Directive 93/42/EEC 2007, Annex IX, and with the company’s quality management system (QMS) certification per EN ISO 13485:2012.

This sample report demonstrates the findings of the review.
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FDA’s Proposed Regulatory Changes to Laboratory-Developed Tests (LDTs)

By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: November 17th, 2014
The FDA has stated that labs can utilize published clinical data for their submissions. Many LDTs have been on the market for a while and have significant published data. Nerac has expertise in conducting clinical literature evaluations and data analysis to support regulatory filings and ongoing regulatory requirements. Read More