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Regulatory

The European In Vitro Diagnostic Regulation: It’s Time to Start Preparing

By Erica Kramer, Ph.D., Nerac Analyst
Originally published November 14, 2017
This article explores the EU In Vitro Diagnostic regulations and the changes manufacturers face. Read more here.

State of the Art for Medical Devices – Applying the Requirements of MEDDEV 2.7/1 Rev. 4

By Nerac Regulatory Analysts
Originally published July 31, 2018
This article explores how to establish and document state of the art in terms of CER requirements.
Read More

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

Webinar: Order 650 – China’s New CLE Requirements for Medical Devices

We invite you to attend our webinar on the clinical literature evaluation process for China.
Learn More 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.
Read More

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.
Read More

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

By Richard Conforti, M.S., Nerac Analyst
Originally Published: April 19, 2016
Understanding CFDA expectations …what you need to know to market your products in China.
Read More

Commercialization Strategy for Innovative Products: The Importance of Considering Regulatory Implications

By Donna Mitchell-Magaldi, M.S., Nerac Analyst
Originally Published: March 8, 2016
You have a great idea for an innovative product, a granted patent, and you are ready to assess market and commercialization feasibility, but do you know the important questions you will need to answer?.
Read More

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.
Read More

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