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.
Services
CE marking conformity assessment
Conformity assessment services to verify device compliance with applicable European regulations and support issuance of CE marking certificates.
QMS certification and surveillance (ISO 13485 / ISO 9001)
Certification audits and issuance of QMS certificates according to ISO 13485 and ISO 9001, including surveillance and renewal audits and related certification lifecycle management.
MDSAP auditing
Single‑audit program audits of manufacturer QMS against participating countries' regulatory requirements with audit reports suitable for regulatory authorities.
Diagnostic audit (QMS readiness assessment)
Pre‑certification sampling audit to identify QMS gaps and provide corrective action recommendations ahead of formal certification.
Express certification coordination
Expedited assessment coordination that prioritizes resources and sequences review activities to shorten standard conformity assessment timeframes where feasible.
Regulatory training, webinars and published guidance
In‑person and virtual training courses, webinars and published guidance on risk management, EU regulations, QMS implementation, clinical evaluation and related regulatory topics.
CE marking conformity assessment
Conformity assessment services to verify device compliance with applicable European regulations and support issuance of CE marking certificates.
QMS certification and surveillance (ISO 13485 / ISO 9001)
Certification audits and issuance of QMS certificates according to ISO 13485 and ISO 9001, including surveillance and renewal audits and related certification lifecycle management.
MDSAP auditing
Single‑audit program audits of manufacturer QMS against participating countries' regulatory requirements with audit reports suitable for regulatory authorities.
Diagnostic audit (QMS readiness assessment)
Pre‑certification sampling audit to identify QMS gaps and provide corrective action recommendations ahead of formal certification.
Express certification coordination
Expedited assessment coordination that prioritizes resources and sequences review activities to shorten standard conformity assessment timeframes where feasible.
Regulatory training, webinars and published guidance
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)