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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

combo ISO 13485 9001


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

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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Santa Clara, CA