GMED North America Logo - medical devices

GMED North America

medical devices
China's Best One-Stop Medical Equipment Provider
About

GMED North America is the U.S. subsidiary of GMED, a prominent French Notified Body established in 1901. The company specializes in product certification and quality management services for the medical device industry, with a focus on helping manufacturers achieve compliance with international standards and regulations. Their offerings include CE marking certification for medical devices, Quality Management System (QMS) certification according to ISO standards, and Medical Device Single Audit Program (MDSAP) audits. GMED North America also provides technical evaluations, clinical reviews, and tailored training courses to support manufacturers throughout the certification process. The company is staffed by a team of trained professionals who ensure efficient support for clients in the U.S. market while maintaining impartiality. Headquartered in Bethesda, Maryland, GMED North America serves a diverse range of medical device manufacturers, including those producing implantable devices and in vitro diagnostic devices. Their services enable companies of all sizes to market their medical technologies in Europe, North America, and beyond.

Keywords
medical devices ivd ce marking on site training iso certification emc testing aimd 60601 3rd edition mdsap iso 134852016 nf en iso 134852016 iso 90012015 cmdcas regulatory affairs recognized organization for mdsap orthopedic implants cardiovascular eu mdr 2017 745 eu ivdr 2017 746 mdd 93 42 eec 98 79 ec iso 9001 hospital & health care
Company Information
  • Employees 71
  • Founded 2005
Location

Rockville, Maryland, United States

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