GMED North America
Medical Equipment Manufacturing • 
Rockville, Maryland, United States • 51-100 Employees
Company overview
| Headquarters | 2600 Tower Oaks Blvd, Suite #500, Rockville, Maryland 20852, US |
| Website | |
| Keywords | Ce Marking, Iso 9001, Medical Devices, Regulatory Affairs, Iso 9001:2015, Emc Testing, Iso Certification, IVD, Mdsap, Cardiovascular, On Site Training, Aimd, Cmdcas, Orthopedic Implants, Iso 13485:2016, Mdd 93/42/Eec, 60601 3Rd Edition, Eu Mdr 2017/745, Eu Ivdr 2017/746, Nf En Iso 13485:2016, Recognized Organization For Mdsap, 98/79/Ec |
| Founded | 2005 |
| Employees | 51-100 |
Key Contact at GMED North America
Marie Abdallah
Compliance Division Director
GMED North America Email Formats
GMED North America uses 2 email formats. The most common is {first name}.{last name} (e.g., john.doe@lne-gmed.com), used 57.7% of the time.
| Format | Example | Percentage |
|---|---|---|
{first name}.{last name} | john.doe@lne-gmed.com | 57.7% |
{first initial}.{last name} | j.doe@lne-gmed.com | 42.3% |
About 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 № 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, 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. GMED’s 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 France and a dedicated US Operation created in 2005 - GMED North America (MD) and a subsidiary created in 2021 – LNE-GMED UK (London), 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.
GMED North America revenue & valuation
| Annual revenue | $7,015,510 |
| Revenue per employee | $86,000 |
| Estimated valuation?This valuation is estimated based on industry average for the Medical Equipment Manufacturing industry and current estimated revenues | $22,500,000 |
| Total funding | No funding |
Employees by Management Level
Total employees: 51-100
Seniority
Employees
Employees by Department
GMED North America has 20 employees across 5 departments.
Departments
Number of employees
Funding Data
GMED North America has never raised funding before.
France
Frequently asked questions
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