Choose GMED

1. Our commitment to our customers

GMED’s success stems from the excellence and commitment shown by its teams, who are highly qualified in current certification assessment and audit methods

In addition, GMED offers a full range of solutions for medical device industry manufacturers to support them throughout their certification process.

Whatever the size, location of your business, and whatever the category of your medical device is, GMED tailors its services to your product and/or quality management system (QMS) certification project.

Lastly, with a presence in Europe, America, as well as in Asia, we serve the medical devices industry worldwide.

2. A multidisciplinary organization

• First, GMED assesses quality management systems against ISO 9001, NF EN ISO 13485, and ISO 13485.
  – In addition, GMED assesses medical device manufacturers under MDSAP.
  – This covers Australia, Brazil, Canada, Japan, and the United States.
• A Notified Body
  GMED, as a notified body, identification number CE 0459, supports you through your medical device certification process for CE marking.
• A Training Organization
  GMED applies its training experience and expertise to help you develop your skills in the medical devices industry.
• An International Player
  GMED participates in working groups and contributes to MDCG guides. It also monitors standardization for the medical devices industry.

3. A team of highly skilled experts

GMED invests in team development. In addition, we recruit experts globally to support current and future projects.

To offer full service, GMED’s auditors are qualified for QMS audits and regulatory assessments.

Therefore, they perform MDSAP, ISO 9001, ISO 13485, CE marking, and UKCA assessments.

This multiple expertise also benefits medical device manufacturers combining certification pathways.

4. A single service provider to assess your product from design to placing it on the market

GMED and its parent company, LNE, allow you to meet the challenges of security, performance and reliability of your medical devices. All your challenges are covered by the LNE Group.

In addition, LNE offers a full range of testing services for all device types. These services include mechanical tests, physicochemical analyses, EMC measurements, and electrical safety. They also include simulations, especially transportation impact and product integrity assessments.

Finally, GMED assesses and certifies the regulatory and technical conformity of your technology.

5. Our passion for innovation

Innovation is the core of our mission. GMED Group is an organization recognized for its experience certifying all types of medical devices, including high-risk products and those including innovative technology.

We keep up with the latest developments in the medical devices industry and the state of the art; our teams have all the qualifications needed to support manufacturers through the certification process as they develop new generations of medical devices.

When selecting a notified body for medical devices, GMED stands out for its predictability, driven by expertise, clear communication, and timeliness. As a trusted notified body partner for medical devices, we provide conformity assessment services that support safe market access.

What sets GMED apart

– Experience you can rely on

GMED offers broad certification coverage across many device types and risk classes. We are designated for 100% of the IVDR scope and nearly 98% of the MDR scope, including high-risk Class D devices.

Our auditors and reviewers bring strong field experience, with 11+ years of seniority for two-thirds of auditors and an average of 5+ years’ product assessment experience among reviewers.

– Clear communication

From onboarding through final assessment, your dedicated GMED Certification Project Manager provides personalized guidance at every step. Our team comprises professionals from 30 nations who speak more than 15 languages, ensuring both local support and international expertise.

Whether through Structured Dialogue sessions or by attending one of the 100+ training sessions led by GMED-qualified experts, which share insights into notified body expectations and regulatory strategy, enjoy transparent, collaborative communication throughout your project.

– Timeliness with structured support

GMED helps keep your project on track with reliable scheduling, responsive management, and visibility into key deadlines.

Our secure digital portal, GMED Connect, provides real-time visibility into your projects, audits, and deadlines, making your experience with our notified body medical devices team more transparent and efficient.