Choose GMED

1. Our commitment to our customers

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

GMED Group 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 Group tailors its services to your product and/or quality management system (QMS) certification project.

With a presence in European Union, United Kingdom and North America, as well as in Asia, we serve the medical devices industry worldwide.

2. A multidisciplinary organization

• A Reference Certification Body in the health care and medical devices industry
  – GMED assesses quality management systems in the healthcare and medical devices industry against ISO 9001, NF EN ISO 13485, ISO 13485 and LNE-GMED UK against BS EN ISO 13485.
  – GMED assesses quality management systems for medical device manufacturers under MDSAP for 5 countries: 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.
• An Approved Body
  Thanks to its subsidiary, LNE-GMED UK, the GMED Group provides you with UKCA marking services.
• 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 numerous working groups and contributes to their work, such as, the guides published by the MDCG (Medical Device Coordination Group). GMED also actively participates in and monitors standardization work that affects the medical devices industry.

3. A team of highly skilled experts

GMED Group invests in its teams’ knowledge and skills development and in an active hiring policy for experts to join its team globally in order to support your current and future projects.

In order to offer a full service to medical device manufacturers committed to ensuring the safety of their devices; GMED Group’s auditors are qualified to perform both quality management system audits (MDSAP, ISO 9001 and ISO 13485), regulatory assessments (CE and UKCA markings).

This multiple expertise offers an advantage to medical device manufacturers who wish to combine 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.

The full range of LNE’s testing services can accommodate all types of devices (mechanical tests, physicochemical analyses, electromagnetic compatibility (EMC) measurement, electrical safety, etc.) and all simulations, particularly including the assessment of the impact of transportation on the product and its integrity. LNE Group offers also, thanks to its subsidiary LNE-GMED UK, full range of certification services including certification for measuring instruments, non-automatic weighing Instruments (NAWI), noise emission in the environment by equipment for use outdoor and construction products.

GMED is there to assess and certify the regulatory and technical conformity of your technology and supports you throughout the duration of your certification projects.

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.