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RAPS 2017 Regulatory Book a MeetingSave the date!
RAPS 2017 - September 9 to 12.

LNE/G-MED NA will participate to RAPS 2017 Regulatory Convergence, at the Gaylord National Resort & Convention Center at National Harbor, MD.

The Regulatory Convergence is RAPS’s annual multi-day gathering of the global regulatory community.

RAPS is the perfect opportunity to meet with our technical experts and discuss your certification project (CE marking, ISO 13485, MDSAP etc.).

 
Come join us in our booth (#625) or set up a time to meet with us while at the conference.

 


Anthony Delamotte LNE G-MED

Ehab Amen LNE Gmed

Sara Jafari LNE Gmed

Anthony Delamotte

Technical Department Director

Ehab Amen

Production Director

Dr. Sara Jafari

PhD, Certification Project
Manager - Active
Medical Devices


Julien Senac LNE Gmed

Florianne Torset Bonfillou LNE Gmed

Jawad Mahdavi LNE Gmed

Dr. Julien Sénac

PhD, Certification Project Manager
and IVD Product Assessor

Florianne Torset- Bonfillou

Director of Regulatory, Education
and Quality - Lead Auditor

Jawad Mahdavi

Medical Device Lead Auditor

Dharmendra Thakur LNE Gmed Mohamed Alsaadi LNE Gmed Ardalan Khosravi LNE Gmed

Dharmendra Takur

Certification Project Manager

Mohamed Alsaadi

Certification Project Manager
Lead Auditor

Ardalan Khosravi

Certification Project Manager
Lead Auditor


 

Our Regulatory and Technical Experts will be speaking
at the following sessions

EU Medical Device Regulations, IVD Workshop
Sunday, September 10th, 2017
Dr. Julien Senac, PhD, Certification Project Manager and IVD Product Assessor

Post Market Surveillance expectation, including Post-Market Clinical Follow up 
Tuesday,  September 12th, 2017
Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality - Lead Auditor
 

 

Book a Meeting:

[Form Raps_2017 not found!]

MDSAP Prepare the transition, worldwide market access

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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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clientsWe're Hiring!

Due to our rapid growth in North America, we're seeking Lead Auditors, Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.

Training - 2 Days Course

Training EU Medical Device Regulations

 

European Medical Device Regulation 2017/745

Click here to Register


 

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

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

Click here to Register

Our Clients Say

"We traveled from Massachusetts to attend the 2days LNE/G-Med ISO 13485:2016 and ISO 9001:2015 transition training and it was well worth the trip. The training was interesting, informative and interactive. The case studies were a great way to try and apply the new aspects of the standards and brainstorm with others. The chance to meet and discuss the new standards with actual LNE auditors was a huge plus."
Dan Massucco - Vice President of Quality Assurance and Regulatory Affairs

"I just thought you might like to know that we completed our transition audit with only three minor NCs. The auditor was very impressed that we did this on our own without the benefit of a consultant. I give much of the credit to your training class and want you to know that I really think you did an excellent job with the training."
Sue Powell - Quality Manager