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The Notified Body Role Medical Device Certification

Join us on Wednesday, January 25th at 2:00 PM Eastern as LNE/G-MED North America Inc. will be hosting a free informative session on the MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)

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In June 2016, the MEDDEV 2.7.1 rev 4, the European guidance on the clinical evaluation of medical devices (MD) was published.

The issuance of this guidance happened shortly after the publication of the text of the future Regulation on the Medical Device (MDR) of 15 June 2016, which anticipates many new requirements for clinical evaluation. Although, the MEDDEV 2.7.1 rev 4 does not revolutionize the approach on Clinical Evaluation, it does significantly increase the demands on the content of the file.

It also shows that the guidance is beginning to align with the upcoming Regulation, a helpful tool for medical device manufacturers looking to operate their transition to the new regulatory requirements. The rev 4 outlines clinical evidence requirements for both unapproved technologies, as well as products that have been on the market for an extended period. 

Join LNE/G-MED and our West Coast Regional Director & Certification Project Manager, Anne Le Rouzo to hear about the key changes introduced by the Revision 4. You can tune to LNE/G-MED North America’s upcoming free webinar on MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER).


Anne Le Rouzo LNE Gmed

Topic: MEDDEV 2.7.1 Rev 4: New Requirements and Changes for Clinical Evaluation Reports (CER)
Date: Wednesday, January 25th, 2017
Time: 2:00 - 2:30 PM Eastern Standard Time

Presenter: Anne Le Rouzo, West Coast Regional Director & Certification Project Manager at LNE/G-MED North America, Inc
Click here to Register!

MDSAP Prepare the transition, worldwide market access

Combo Training ISO13485 MDSAP


We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States


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Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

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