Medical Device Certification and Compliance
GMED is a leading Certification Organization and Notified Body (CE0459) authorized to conduct conformity assessment procedures for medical devices under European regulations. The company specializes in evaluating medical devices and in-vitro diagnostics, reviewing design dossiers and technical documentation to verify compliance with relevant standards and regulations. GMED is authorized to act under European Regulation (EU) 2017/745 on medical devices and several European Directives, determining whether devices meet safety and efficacy requirements for CE marking certification. GMED North America serves as the US subsidiary of the broader GMED organization.
Industry
Medical Device Certification and Compliance
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