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Product Certification and Quality Management System (QMS) services. A complete certification package to save you the time and costs.

CE mark, Active Implantable Medicale Devices, In Vitro Diagnostics, Single Audit Program, ISO 13485, ISO 9001.

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One of Europe’s Largest Testing Facility. Offer a complete range of standardized tests or customize tests for characterization.

Electromagnetic Compatibility (EMC), Electrical Safety, CB Scheme, Charpy reference specimens.

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A Training Organization with customized courses. Public, online our at your site, our Experts use practical examples in a dynamic and interactive atmosphere.

Check our Training List: ISO 9001:2015 and ISO 13485:2016 Transition, Sterilization Process, Software Lifecycle Processes, etc.

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Get the latest news on EU directives, Quality Standards and other important Regulatory Developments, along with practical Guidance for Compliance.

News, Technical Guides, Newsletter and Webinars.

Latest News

MDSAP Program Is Now Utilized by 2 Other Countries: South Korea and Argentina

  • April 02 - 2020

South Korea (Ministry of Food and Drug Safety) first and now Argentina (ANMAT) have very recently joined the MDSAP program as affiliated members. Although not an observer, like the WHO or the European Union, nor a member of the consortium of regulatory authorities at the initiative of the program...

GMED's Business Continuity Plan in the Context of the COVID-19 Health Crisis

  • March 17 - 2020

As the COVID-19 crisis evolves and is now officially a pandemic, we are taking additional security measures to protect our employees, partners, and customers. We have implemented a business continuity plan that ensures the health and safety of our employees, their families and the customers we...

Information Related to the COVID-19 Coronavirus Health Crisis

  • March 11 - 2020

GMED implemented exceptional provisions to ensure the protection of its employees,  suppliers and customers in the context of the health crisis linked to the coronavirus (COVID-19). A coordination and monitoring unit has been set up at the LNE Group level, including GMED and GMED North...

Health Canada Releases a Guidance Document Defining Pre-market Requirements for Medical Device Cyber-security

  • August 06 - 2019

In an effort, to mitigate, potential cybersecurity threats due to the increasing levels of interconnectedness and data exchange between medical devices— Health Canada has released a guidance document on “pre-market requirements for medical device cybersecurity.” The guidance document defines...

Note from the Irish and German Delegations on the Implementation of Regulation (EU) 2017/745 on Medical Devices

  • July 09 - 2019

On June 6th, 2019 the European Union released a document, with a note from the Irish and German Delegations on the implementation of Regulation (EU) 2017/745 on medical devices. The document addresses the increased number of discussions regarding the challenges and concerns facing stakeholders...

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