G-MED
GMED SAS
GMED is a Notified Body and certification organization specializing in medical devices. They offer conformity assessments, QMS certification, and training to help manufacturers navigate global regulations.
GMED, a subsidiary of LNE (French National Metrology and Testing Laboratory), is a leading international certification body for medical devices and quality management systems. With over 30 years of experience, GMED assesses conformity for manufacturers worldwide, enabling market access. They provide comprehensive services including CE Marking, QMS Certification (ISO 13485, ISO 9001), and MDSAP Program support. GMED also offers tailored training courses, both in-person and online, through its North American Training Center, focusing on risk management and EU regulations. GMED's expertise extends to various device categories, including implantable, electromedical, and in vitro diagnostic devices. They are committed to patient safety and streamlined regulatory processes, acting as a strategic partner for companies of all sizes navigating complex certification landscapes.
About
**Who they are**
G-MED is a Notified Body and certification organization focused on medical devices. They assist manufacturers in navigating global regulatory landscapes.
**Expertise & scope**
* Conformity assessments for medical devices
* Quality Management System (QMS) certification
* Training services for regulatory compliance
* Support for manufacturers to meet global regulations
**Reputation / proof points**
* Designated as a Notified Body
* Specializes in medical device certification
G-MED is a Notified Body and certification organization focused on medical devices. They assist manufacturers in navigating global regulatory landscapes.
**Expertise & scope**
* Conformity assessments for medical devices
* Quality Management System (QMS) certification
* Training services for regulatory compliance
* Support for manufacturers to meet global regulations
**Reputation / proof points**
* Designated as a Notified Body
* Specializes in medical device certification
Additional information
G-MED's services are designed to guide medical device manufacturers through complex regulatory requirements. Their expertise extends to ensuring that Quality Management Systems meet established standards, a critical step for market access in the EU. They also provide training to enhance manufacturers' understanding of and adherence to these regulations. Engagement with G-MED typically involves detailed assessments and certification processes aimed at validating device compliance.
Key Highlights
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G-MED is a Notified Body and certification organization.
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“GMED is a Notified Body and certification organization”
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Specializes in medical devices.
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“specializing in medical devices.”
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Offers conformity assessments for medical devices.
Source
“They offer conformity assessments”
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Provides Quality Management System (QMS) certification.
Source
“QMS certification”
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Delivers training to help manufacturers navigate global regulations.
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“and training to help manufacturers navigate global regulations.”
Certifications & Trust Signals
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Designated as a Notified Body for medical devices.
Source
“GMED is a Notified Body”
Buyer Snapshot
Best for
- Medical device manufacturers seeking EU certification
- Companies needing QMS certification
- Organizations requiring regulatory training
How engagement typically works
- Formal assessment and certification process
- Training and guidance on regulatory compliance
Typical deliverables
- Conformity assessment reports
- QMS certification
- Regulatory training completion
Good to know
- Best when focused on medical device sector
- Requires manufacturer engagement in assessment and QMS implementation
HQ:
Paris, FR
Languages:
English, French
Timezones:
Europe/Brussels
Claim status:
Listed
Services & Capabilities
Find EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
NL, IT, SE, BE, DE, ES
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
100+
Onboarding time:
2–14 days
Pricing model:
Retainer
Starting from:
EUR 5,000
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Vigilance, Not sure
Supports Training Enablement:
Yes
Data Load Support Level:
Guided
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
Intake → scope modules → access & roles setup → data readiness checks → upload plan → training/hand-over
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Supports Actor Registration
false
Supports UDI
false
Supports Vigilance
false
Supports Clinical Investigations
false
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