GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459) whose scope covers all of the European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC). An Auditing Organization Recognized by the MDSAP Regulatory Authority Council, GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate № 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according to ISO 9001:2015 and ISO 13485:2016. With offices in Europe and North America, GMED offers the convenience and efficiency of local teams of experts to serve you.
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Bethesda, Maryland 20817