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ISO Certification

iso 13485 certification processThe International Organization for Standardization (ISO) develops standards that help companies monitor and improve their processes and products, in terms of Quality, Environment, Impact, Safety, Reliability, Efficiency and Interchangeability.

Recognized worldwide by Regulatory Affairs Professionals and Quality Managers, ISO bridges the national standards institutes of 159 countries.

A company that demonstrates adherence to specific standards can earn credibility with its customers, investors, employees and other stakeholders. In addition, many countries mandate certain ISO certifications prior to granting a manufacturer approval to sell products.

Demonstrate Adherence to World Standards through Independent Certification

Regulators rely on the work of accredited third parties to audit companies to ISO standards.

LNE/G-MED is authorized to certify a variety of ISO standards, including:

iso standards medical devices Contact us today for ISO registration.

MDSAP Prepare the transition, worldwide market access

Questions?

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