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LNE, a Driver for Competitiveness and SafetyLNE corporate ce notified body

Our business is to create references and measurement methods in all technical fields (energy, environment, electricity, safety, chemistry, mechanics, statistics, quality management systems, etc.).

Our objective: to provide our customers with benchmarks and reliable results and to enable them to implement their own strategies.

Our method: to mobilise the human and technical resources required to find appropriate solutions for the various requirements of our five business divisions (research and transfer, technical support, testing and calibration, certification, training and information)...


LNE/G-MED Medical HealthLNE G-MED medical device, your certification notified body

LNE/G-MED's Medical-Health teams provide support and a personalized response to many actors intending to increase international growth and reduce time-to-market while complying with European and international regulations.

As medical devices become more sophisticated, their regulatory compliance strategy must also evolve to solve the challenges.

From our offices in the United States and France, we can certify your quality management system and products for Europe and other international juridictions, helping you benefit from our accreditations and regulatory recognition...


 

Questions?

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

   1-301-495-0477

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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