GMED North America, Inc.
GMED is a globally recognized leader in medical device certification, offering a wide range of certification, training, and testing services. With over 30 years of experience, GMED supports medical device manufacturers in achieving compliance with international standards and regulations, including CE marking, ISO 13485, and MDSAP. As a subsidiary of the French National Metrology and Testing Laboratory (LNE), GMED maintains high standards of impartiality and expertise, serving markets in Europe, North America, Asia, and beyond. The company is committed to health, innovation, and excellence in the medical device industry.
Industries
Nr. of Employees
small (1-50)
GMED North America, Inc.
2600 Tower Oaks Blvd, Suite 500 Rockville, MD 20852, United States of America
Services
Conformity assessment services to verify device compliance with applicable European regulations and support issuance of CE marking certificates.
Certification audits and issuance of QMS certificates according to ISO 13485 and ISO 9001, including surveillance and renewal audits and related certification lifecycle management.
Single‑audit program audits of manufacturer QMS against participating countries' regulatory requirements with audit reports suitable for regulatory authorities.
Pre‑certification sampling audit to identify QMS gaps and provide corrective action recommendations ahead of formal certification.
Expedited assessment coordination that prioritizes resources and sequences review activities to shorten standard conformity assessment timeframes where feasible.
In‑person and virtual training courses, webinars and published guidance on risk management, EU regulations, QMS implementation, clinical evaluation and related regulatory topics.
Conformity assessment services to verify device compliance with applicable European regulations and support issuance of CE marking certificates.
Certification audits and issuance of QMS certificates according to ISO 13485 and ISO 9001, including surveillance and renewal audits and related certification lifecycle management.
Single‑audit program audits of manufacturer QMS against participating countries' regulatory requirements with audit reports suitable for regulatory authorities.
Pre‑certification sampling audit to identify QMS gaps and provide corrective action recommendations ahead of formal certification.
Expedited assessment coordination that prioritizes resources and sequences review activities to shorten standard conformity assessment timeframes where feasible.
In‑person and virtual training courses, webinars and published guidance on risk management, EU regulations, QMS implementation, clinical evaluation and related regulatory topics.
Expertise Areas
- Regulatory compliance for medical devices (MDR, IVDR and legacy directives)
- Quality management system certification and auditing (ISO 13485, ISO 9001)
- MDSAP and multi‑jurisdictional QMS assessment
- Notified body conformity assessment and post‑certification surveillance
Key Technologies
- ISO 13485 quality management framework
- ISO 9001 quality management framework
- MDSAP audit methodology
- EU conformity assessment procedures (MDR / IVDR)
News & Updates
A conference in Boston, Massachusetts, on June 10-12, 2025, focusing on post-market surveillance and vigilance.
A virtual classroom training on June 16-17, 2025, covering risk management in medical devices.
An event in Berlin, Germany, from June 16-20, 2025, focusing on medical technology innovations.
GMED is recognized as an auditing organization by the MDSAP Regulatory Authority Council, participating since 2015.
An article discussing the ISO 10993 series for biological evaluation of medical devices.
Information about the new MIR 7.3.1 form required from November 2025.
A conference in Boston, Massachusetts, on June 10-12, 2025, focusing on post-market surveillance and vigilance.
A virtual classroom training on June 16-17, 2025, covering risk management in medical devices.
An event in Berlin, Germany, from June 16-20, 2025, focusing on medical technology innovations.
GMED is recognized as an auditing organization by the MDSAP Regulatory Authority Council, participating since 2015.
An article discussing the ISO 10993 series for biological evaluation of medical devices.
Information about the new MIR 7.3.1 form required from November 2025.