LNE/G-MED
GMED (GMED SAS) is a French notified body (ID 0459) providing CE marking, ISO 13485 QMS certification, and MDSAP audits to medical device and IVD manufacturers seeking regulatory market access across Europe, North America, and Asia as a wholly-owned subsidiary of state-owned LNE.
- Company typePrivate
- Founded1979
- HeadquartersParis, France
- Headcount11–50
- GTM typeB2B
- OfferingServices
What LNE/G-MED does
GMED (legal entity GMED SAS) is a French notified body and certification organization designated as Notified Body ID 0459 by the French Health Authority (ANSM) under EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). The company delivers conformity assessment, quality management system (QMS) certification, and multi-jurisdictional audit services to medical device and IVD manufacturers, with 100% IVDR scope coverage and nearly 98% MDR scope coverage including high-risk Class D devices. Core certification products are CE Marking (under MDR/IVDR), QMS Certification (ISO 13485:2016 and ISO 9001:2015 under COFRAC accreditation no. 4-0608), and MDSAP certification enabling access across the US, Canada, Brazil, Australia, and Japan. Services are delivered through a multilingual team drawn from 30+ nationalities and supported by the GMED Connect digital portal for project management and a 100+ session annual training catalogue. Operations span four offices: Paris and Saint-Étienne in France, Rockville (Maryland, USA), and Hong Kong, with UK operations led through LNE-GMED UK.
GMED is a wholly-owned subsidiary of LNE (Laboratoire National de Métrologie et d'Essais), a French state-owned industrial and commercial institution under the Ministry of Economy and Finances, formed on August 1, 2018 when the certification function was separated from LNE. Additional recognitions include MDSAP Auditing Organization status since April 2015, MRA coverage with Australia/New Zealand, TCP III recognition by Taiwan TFDA since January 2022, and SAHPRA recognition in South Africa since July 2025. Revenue is generated through quote-based, multi-year certification contracts (typically three-year cycles with annual surveillance audits), professional training services, and is supplemented by integrated testing capabilities through parent LNE covering mechanical, physicochemical, EMC, and electrical safety testing. End-customers include medical device manufacturers across device classes (e.g., imaging equipment, implants, electromedical devices, software as a medical device) and IVD manufacturers; named customers include Median Technologies (ISO 13485 for AI SaMD) and Profusa (CE Mark for an oxygen platform).
LNE/G-MED firmographics
Firmographics- Name
- LNE/G-MED
- Legal name
- GMED SAS
- Website
- https://lne-gmed.com
- Company type
- Private
- Founded year
- 1979
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- GMED (GMED SAS) is a French notified body (ID 0459) providing CE marking, ISO 13485 QMS certification, and MDSAP audits to medical device and IVD manufacturers seeking regulatory market access across Europe, North America, and Asia as a wholly-owned subsidiary of state-owned LNE.
- Ownership category
- akta.pro rank
LNE/G-MED industry classification
Industry- Product category
- Medical Device Certification & Regulatory Compliance Services
- NAICS
- Testing Laboratories and Services (54138)
- SIC
- Services-Testing Laboratories (8734)
- akta.pro primary industry
- Manufacturing Quality, GMP Inspections & Compliance (HLAJADAG)
- akta.pro secondary industry
- GMP Manufacturing Support Services (QA/QMS, validation, documentation) (HLAAAKAH)
Keywords
Where LNE/G-MED is headquartered
LocationHeadquarters
- HQ city
- Paris
- HQ country
- France
- HQ region
- Europe
Offices4 records
Markets served
LNE/G-MED business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure
Revenue model
- CE Marking Certification Services: Fees for conformity assessment activities under EU MDR and IVDR regulations, including technical documentation review, quality system assessments, and certificate issuance for medical devices
- QMS Certification Services: Quality Management System certification services under ISO 13485 and ISO 9001 standards, including initial audits, surveillance audits, and renewal audits
- MDSAP Certification Services: Medical Device Single Audit Program certification enabling market access across five countries (US, Canada, Brazil, Australia, Japan) through single QMS assessment
- Training Services: Professional training courses for medical device industry professionals covering EU MDR, IVDR, ISO 13485, risk management, clinical evaluation, and technical documentation
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | CE Marking certification fees based on device class and assessment complexity |
| Other | Multi-year contract | QMS certification fees including initial audit, surveillance audits, and renewal |
| Other | Annual | MDSAP certification for multi-country market access |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
LNE/G-MED product offering
Product offeringCore offering
GMED is a notified body (ID 0459) providing conformity assessment and certification services for medical device and in vitro diagnostic manufacturers. Its core offerings include CE Marking certification under EU MDR 2017/745 and IVDR 2017/746, QMS certification against ISO 13485:2016 and ISO 9001:2015, and MDSAP audits enabling single QMS recognition across the US, Canada, Brazil, Australia, and Japan. These services are complemented by professional training programs delivered through the GMED Training Center and project management via the GMED Connect digital portal.
Product overview
GMED is a notified body and international certification organization providing conformity assessment and certification services for medical device manufacturers. The company operates as a unified service portfolio organized around three core certification products: CE Mark Certification (covering MDR and IVDR compliance), QMS Certification (ISO 13485 and ISO 9001), and MDSAP Certification (multi-country QMS recognition). These core offerings are supported by a GMED Training Center offering professional development courses, GMED Connect customer portal for project management, and specialized focus areas for Medical Devices, Electromedical Devices, and In Vitro Diagnostic Medical Devices. The company also provides a Certificate Repository and Knowledge Center as supplementary resources. GMED is designated as Notified Body 0459 under EU regulations and is a wholly-owned subsidiary of LNE (Laboratoire National de Métrologie et d'Essais), with subsidiaries in North America (Rockville, Maryland) and Asia (Hong Kong).
Differentiator
Problem solved
Functional benefit
Products and services
- CE Mark Certification
Quantifiable outcome
- Broad certification coverage across many device types and risk classes
- +1 more outcomes
Companies that use LNE/G-MED
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles4 records
LNE/G-MED technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature2 records
LNE/G-MED partnerships and signals
Strategic signalPartnerships
Four partnerships are on record, tiered minor and core.
- SAHPRA (South African Health Products Regulatory Authority)minorGMED has been recognized by South African Health Products Regulatory Authority as a conformity assessment body to conduct audits in accordance with ISO 13485:2016 since July 2025.
- TFDA (Taiwan Food and Drug Administration)minorUnder Technical Cooperation Program (TCP) III, GMED is recognized by Taiwan's Ministry of Health to perform ISO 13485 audits, enabling European manufacturers to use GMED reports for Taiwan market access.
- LNE (Laboratoire National de Métrologie et d'Essais)coreLNE is the French National Metrology and Testing Laboratory and parent company of GMED SAS. LNE was created in 1901 and is a state-owned industrial and commercial institution under the authority of the Economy and Finances Ministry. GMED became a wholly-owned subsidiary of LNE on August 1, 2018. LNE provides testing services including mechanical tests, physicochemical analyses, EMC measurements, electrical safety, and simulations that complement GMED's certification services.
- Team-NBminorGMED is a member of Team-NB, the European Association of Notified Bodies. The association works to establish best practices, promote technical and ethical standards, and participate in developing the legal framework for medical device regulation.
Scale indicators6 records
Recent moves11 records
Expansion highlights6 records
LNE/G-MED competitors and assessment
Company assessmentDirect peers
- TÜV SÜD: One of the largest EU notified bodies (ID 0123) for medical devices under MDR/IVDR, with global offices and a comparable service portfolio spanning CE marking, ISO 13485, and MDSAP. Direct head-to-head competitor for the same manufacturer base.
- BSI Group: UK-based notified body (BSI 0086) designated under EU MDR/IVDR with broad scope coverage and ISO 13485 certification services. Closely comparable in scope breadth, geographic reach, and reliance on European regulatory frameworks.
- DEKRA: Major European testing, inspection, and certification organization with a notified body function for medical devices. Competes directly for CE marking, QMS, and MDSAP engagements, with a comparable mix of in-house testing and certification.
- TÜV Rheinland: German notified body (ID 0197) offering MDR/IVDR conformity assessment, ISO 13485 certification, and MDSAP audits globally. Closely comparable scale, scope, and customer profile to GMED.
- DNV: Norwegian-headquartered certification body with notified body services for medical devices and significant healthcare/supply chain certification operations. Competes in the same ISO 13485 and CE marking markets, often pitching to the same large manufacturers.
- Intertek: Global testing, inspection, and certification company with medical device certification services (notified body status in several EU jurisdictions) and an MDSAP footprint. Comparable across CE marking, ISO 13485, and adjacent compliance testing.
- SGS: Swiss-headquartered TIC company with notified body activity for medical devices and a global life sciences certification practice. Competes for ISO 13485, CE marking, and multi-jurisdictional QMS engagements, often against GMED for the same enterprise customers.
- Bureau Veritas: French-headquartered TIC firm with a healthcare and medical device certification arm providing ISO 13485 and CE marking services. Domestic French overlap with GMED makes it a particularly direct competitor in the home market.
Broad incumbents
- UL Solutions: Global safety science and certification company with a notified body function for medical devices in several EU member states. Overlaps in CE marking, ISO 13485, and active medical device safety certification, particularly for electromedical devices.
Emerging players
- NSAI (National Standards Authority of Ireland): Irish notified body with MDR/IVDR designation, providing CE marking and ISO 13485 services. Smaller scale than GMED but a comparable European designated alternative for manufacturers seeking a mid-sized notified body.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat4 records
Key risks5 records
Key highlights6 records
Customer concentration
LNE/G-MED social profiles
Digital presenceLNE/G-MED compliance and trust
Trust signalCompliance11 records
LNE/G-MED financial estimates
Financial estimateRevenue estimate
Valuation estimate
LNE/G-MED leadership team
Management profileNumber of profiles
Profiles11 records
LNE/G-MED subsidiaries and ownership
Company hierarchySubsidiaries2 records
LNE/G-MED funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
LNE/G-MED M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about LNE/G-MED
What does LNE/G-MED do?
GMED is a notified body (ID 0459) providing conformity assessment and certification services for medical device and in vitro diagnostic manufacturers. Its core offerings include CE Marking certification under EU MDR 2017/745 and IVDR 2017/746, QMS certification against ISO 13485:2016 and ISO 9001:2015, and MDSAP audits enabling single QMS recognition across the US, Canada, Brazil, Australia, and Japan. These services are complemented by professional training programs delivered through the GMED Training Center and project management via the GMED Connect digital portal.
Is LNE/G-MED a public or private company?
LNE/G-MED is a private company. It is classified as state government owned and is currently operating.
When was LNE/G-MED founded?
LNE/G-MED was founded in 1979. It employs 11 to 50 people.
Where is LNE/G-MED based?
LNE/G-MED is headquartered in Paris, France, in the Europe region.
How does LNE/G-MED make money?
Four revenue lines are on record. CE Marking Certification Services are the primary driver. The others are QMS Certification Services, MDSAP Certification Services and training Services.
Who are LNE/G-MED's main competitors?
Direct peers on record are TÜV SÜD, BSI Group, DEKRA, TÜV Rheinland, DNV, Intertek, SGS and Bureau Veritas. UL Solutions is listed as a broad incumbent. NSAI (National Standards Authority of Ireland) is listed as an emerging player.
Does LNE/G-MED have an API?
No public API is recorded for LNE/G-MED.
What industry is LNE/G-MED in?
LNE/G-MED's product category is Medical Device Certification & Regulatory Compliance Services. Its primary akta.pro industry code is HLAJADAG, Manufacturing Quality, GMP Inspections & Compliance, with a secondary code of HLAAAKAH, GMP Manufacturing Support Services (QA/QMS, validation, documentation). Its NAICS code is 54138 and its SIC code is 8734.