GMED North America

GMED North America

Medical Device

Rockville, Maryland 7,014 followers

GMED North America is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459)

About us

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.

Website
https://lne-gmed.com/
Industry
Medical Device
Company size
51-200 employees
Headquarters
Rockville, Maryland
Type
Privately Held
Founded
2005
Specialties
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

Locations

Employees at GMED North America

Updates

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    GMED North America Team Week 2024 was a blast!   Our team enjoyed a week filled with collaborative sessions on EU-MDR / IVDR requirements, tools, and methodologies aimed at increasing efficiency and predictability, benefiting both industry and patient safety. The sessions were highly informative and empowering. It was also an opportunity to strengthen our team spirit with skill development sessions, team building, and fun activities.   GMED North America Team Week highlights: • At GMED, we proudly celebrate our rich diversity and inclusion. Our team hails from over 29 nations, speaks over 15 languages, and maintains a balanced gender representation. This multicultural environment fosters innovation, collaboration, and a truly global perspective • The company has an employee turnover rate of 7%, half compared with the industry average, ensuring the sustainability of our expertise • Almost 75% of our product reviews (MDR/IVDR) are completed under 3 rounds and certification decisions are completed on average in 2 months for MDSAP, 7 months for IVDR, and 12 months for MDR, humbly filling our team with pride in our efficiency.   Kudos also go to the organizers and animators of the various events and workshops: Nina A., Marzieh Shafikhani, Erin McCormick, Catherine G., Celeste Gomez, Ahmad Abdulaziz, M.S., Nathalie MORIN, Razan Barakat, Aminata Cisse, Pharm.D, PMP, Zineb Belmkaddem, Rifka Herman, Sarah Coviaux, Fatimazahra Meskini, Can Orhun, Ehab A., Cem Cakirer, Emmanuel J. Arri, Marie Abdallah, Tarik Krim   #ProudOfOurTeams #RegulatoryCompliance #MedicalDevices

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    AI Act: publication in the OJEU On July 12th, 2024, Regulation (UE) 2024/1689 was published in the Official Journal of the European Union (OJEU). Better known as the “AI Act”, this regulation sets a framework around the development and the distribution of artificial intelligence systems, and applies notably to medical devices. GMED has been mobilizing its resources for the past months, and created an AI working group, to respond as effectively as possible to these changes in the regulatory and standards landscape. To read the full News: https://lnkd.in/ex5JsUXq #OJEU #AI #medicaldevices

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    Manufacturers, are you IVDR-compliant ready? The Regulation (EU) 2017/746 (IVDR) has brought a pivotal shift in the landscape of in vitro diagnostic devices within the European Union. Compared with the Directives, the number of devices subject to the regulation has risen strongly, while the number of IVDR-certified Notified Bodies is much lower. GMED, for its part, has been successfully delivering IVDR certifications to manufacturers since March 2022. As this new regulation takes effect, IVDR-compliant devices give you a competitive edge and new market opportunities. It’s crucial for manufacturers to be well-informed and proactive, as waiting until the eleventh hour risks delays and bottlenecks. To experience a smooth IVDR certification with a responsive notified body that has a well-established and defined process, contact us at request@lne-gmed.com or visit our contact page: https://lnkd.in/dNJfZwAi

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    Chris Brodrick, Product Reviewer, delivered a presentation at the US Annual Medical Device and Diagnostic Post-Market Surveillance & Vigilance Conference 2024 entitled “Mastering PSURs: A Roadmap to Structuring Comprehensive PSURs”. His talk opened up conversations with manufacturers, who shared their perspectives on PMS-related concerns. Notable takeaways included: • PSUR Preparedness: Among the numerous attendees, less than a handful had prepared PSURs and most are looking for support. • IMDRF Code Challenges: Manufacturers face difficulties adapting the codes they use across different world regions to the harmonized IMDRF codes. GMED’s Post-Market Surveillance and Vigilance training program is tailored to support manufacturers in identifying and implementing key regulations requirements. Don’t miss our next sessions: https://lnkd.in/gHj2R86 If you have any questions, do not hesitate to contact us: gmedna-training@lne-gmed.com

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    #BundleOfferIVDR Don't miss your chance to save $350! GMED North America’s training Center has launched a new training package. Enroll in our European in Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR) training on August 27-28 and our Technical Documentation per In Vitro Diagnostic Devices Regulation (EU) 2017/746 training on October 15-16 to save up to $350. Sign up today and secure your discount: https://lnkd.in/ejYwqg9V Questions? Contact gmedna-training@lne-gmed.com

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    1st revision of the MDCG 2021-5 guidance on standardisation for medical devices This document aims to provide guidance relating to the medical devices sector standards, in support of the requirements laid down in the applicable EU legislation. The revisions are made as following: - Removal of reference to directives and integration of those onto the regulations - New considerations for the use of standards EN ISO 15189 and ISO 14155:2011 - New reference to the MDR/IVDR standardization mandate and its amendments - Updates on the role of “state of the art” in the standardisation and its definition - Additions of reference to the European Court of Justice rulings to the European Pharmacopoeia and to common specifications

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    #UpcomingTraining August 27-28: European in Vitro Diagnostic Devices Regulation (EU) 2017/746 Join our comprehensive 2-day virtual training to identify key changes between the Directive and Regulation, comprehend new regulatory requirements, and understand the Regulation's structure. Learn more and register today: https://lnkd.in/eca9M2e4 Save up to $350 by bundling this training with our October 15-16 Technical Documentation per IVDR (EU) 2017/746 training. Bundle now and save: https://lnkd.in/ejYwqg9V Questions? Contact: gmedna-training@lne-gmed.com #training #IVDR #EUIVDR

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    Regulation (EU) 2024/1860: Extension of the IVDR transitional period and other provisions The Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) has been published in the Official Journal of the European Union (OJEU). The aim of this legislation is to ensure continuity of supply on the European market for in vitro diagnostic devices. It also amends the provisions relating to the compulsory use of EUDAMED for devices that comply with one of the regulations or were placed on the market under one of the directives (legacy devices). Lastly, the text introduces the obligation for manufacturers and all economic operators in the supply chain to declare supply disruptions or risks of supply disruptions. To help you understand the ins and outs of this new text, GMED has analyzed the different key paragraphs and the impact for manufacturers and notified bodies. Learn more about our analysis: https://lnkd.in/exnS3i_a #EUDAMED #regulation #IVDR #MDR #OJEU

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    #UpcomingTraining September 10-12 (half-days): Medical Device Electrical Safety Participate in our 2-day virtual training course, conducted over 3 consecutive half-days, to understand the electrical safety requirements per IEC 6061-1 A1/A2. Learning Objectives: - Determine the applicable medical equipment requirements to design products for compliance; - Define insulation parameters and requirements; - Evaluate creepage, clearance, insulation thickness and dielectric strength requirements; - Learn about appropriate grounding / earthing, fire protection and mechanical requirements; - Create accurate and concise design and purchase specifications for critical components to achieve safety compliance goals; - Identify performance testing, marking, documentation requirements. Register today and learn more: https://lnkd.in/eTgk3FVb For more info, contact gmedna-training@lne-gmed.com #MedicalDeviceElectricalSafety #MedicalDeviceTraining #VirtualTraining #IEC20201

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    #NewTraining  October 15 – 16: Technical Documentation per In Vitro Diagnostic Devices Regulation (EU) 2017/746 Don’t miss out on our new 1.5-day virtual training program designed to assist in vitro diagnostic medical device companies in identifying and understanding the key elements required to establish their technical file as part of their CE marking application process. Learning Objectives: - Identify the component parts of technical documentation for establishing the conformity of in vitro diagnostic medical devices in line with the requirements of the European Regulation - Identify the best practices for structuring the technical documentation in line with the expectations of certified bodies and competent authorities in charge of medical devices and market surveillance Check out the program here: https://lnkd.in/ev7Vihgr Questions? Contact gmedna-training@lne-gmed.com 

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