GMED North America

GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) and assesses the conformity of medical devices and in vitro diagnostic medical devices in accordance with European Regulations (EU) 2017/745 and (EU) 2017/746 and carries out the activities required to maintain certificates under Directives (90/385/EEC, 93/42/EEC and 98/79/EC). GMED is also an Auditing Organization Recognized by the MDSAP Regulatory Authority Council and has been performing MDSAP audits since April 2015. GMED is accredited under the NF EN IEC/ISO 17021-1:2015 standard by COFRAC (Certificate No 4-0608), the French Accreditation Committee, to carry out Quality Management System Certification activities according...

Medical devices,ivd,ce marking,on site training,iso certification,emc testing,aimd,60601 3rd edition,mdsap,iso 13485:2016,nf en iso 13485:2016,iso 9001:2015,cmdcas,regulatory affairs,recognized organization for mdsap,orthopedic implants,cardiovascular,eu mdr 2017/745,eu ivdr 2017/746,mdd 93/42/eec,and 98/79/ec

Gmed north america operates in the Medical device industry.

Gmed north america's revenue is 11m - 100m

Gmed north america has 51 - 200 employees.