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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


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, Medical Device Clinical Expert, Production Coordinator , Certification Project Manager Active and Non-Active Medical Device responsible for medical device manufacturing clients.