Gmed North America
Other, 8000 York Rd, Rockville, Maryland, 21252, United States, 51-200 Employees
Phone Number: 30********
Who is GMED NORTH AMERICA
GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC an...
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- Headquarters: 8000 York Rd, Rockville, Maryland, 21252, United States
- Date Founded: 2005
- Employees: 51-200
- Revenue: $1 Billion and Over
- Active Tech Stack: See technologies
- CEO: Tarik Krim
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Frequently Asked Questions Regarding GMED North America
Answer: GMED North America's headquarters are located at 8000 York Rd, Rockville, Maryland, 21252, United States
Answer: GMED North America's phone number is 30********
Answer: GMED North America's official website is https://lne-gmed.com
Answer: GMED North America's revenue is $1 Billion and Over
Answer: GMED North America's SIC: 8011
Answer: GMED North America's NAICS: 621111
Answer: GMED North America has 51-200 employees
Answer: GMED North America is in Other
Answer: GMED North America contact info: Phone number: 30******** Website: https://lne-gmed.com
Answer: GMED is a leading Certification Organization and a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device 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 to ISO 9001:2015 and ISO 13485:2016. Established in 1994, GMED is fully owned by LNE (e.1901), a State-owned Industrial and Commercial Establishment (EPIC), and operates since August 1st, 2018 as a simplified joint-stock company (SAS) within the LNE group. GMEDs success and performance rely on a strong and dedicated team of individuals, trained to the highest level of assessment and auditing methods, to provide the best in medical device certification services: Certification Project Managers, Subject Matters Specialists (MDAO or Medical Device Animal Origin, Medicinal Substance, Active Implantable Medical Devices, Microbiologists), Technical Documentation Evaluators and Design Dossier Assessors, Clinical Reviewers & Experts (Ex: Sterilization Methods and Validation) and Auditors for CE marking and QMS activities. With offices in Europe and a dedicated US Operation created in 2005 - GMED North America (MD), GMED offers the convenience and efficiency of local teams of experimented specialists to accompany your certification process which will allow you to market your technologies into dedicated targeted areas of the world.
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