First revision of the MDCG 2023-3: Q&A on vigilance terms and concepts as outlined in the Regulations (EU) 20217/745 and 2017/746 In November 2024, the MDCG published a revision of the several questions listed in its Q&A on vigilance terms and concepts as outlined in the MDR and IVDR. On a general note, new questions were added, the term ‘Regulations’ and references to IVDR articles were inserted, adjustments all over the document to align it to the latter were made, and a table of contents was included?to provide a general overview of the document.
GMED North America
医疗设备
Rockville，Maryland 7,435 位关注者
GMED North America is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459)
关于我们
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.
- 网站
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https://lne-gmed.com/
GMED North America的外部链接
- 所属行业
- 医疗设备
- 规模
- 51-200 人
- 总部
- Rockville，Maryland
- 类型
- 私人持股
- 创立
- 2005
- 领域
- 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和98/79/EC
地点
GMED North America员工
动态
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Q&A on the obligation to inform in case of interruption or discontinuation of supply of certain MDs and IVDs The European Commission has published a Q&A on the practical aspects related to the implementation of the obligations, laid down in Article 10a, to inform the Competent Authorities, the economic operators, and all other relevant actors, in case of interruption or discontinuation of supply of certain MDs and IVDs, as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746. #MDR #IVDR #medicaldevices #invitromedicaldevices #Article10a #europeancommission
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We are excited to announce our 2025 Training Calendar! Our comprehensive program has 9?additional training courses?among 21?online and newly added in-person offerings, all designed to help you understand and face?regulatory compliance, risk management, and quality management systems challenges. The first training courses of the new year are: European Medical Device Regulation (EU) 2017/745 Risk Management Applied to Medical Devices (ISO 14971:2019) European in vitro Diagnostic Device Regulation (EU) 2017/746 Led by our team of seasoned experts, each course features insightful presentations and hands-on working sessions aimed at providing practical knowledge and skills. Don't miss out on the opportunity to enhance your expertise! Explore our interactive calendar and book a training today: https://lnkd.in/e7PWXxdK For any questions or further information, please contact us at [email protected] or visit https://lnkd.in/eNxSgUeq. #medicaldevicetraining #virtualtraining #regulatorycompliance #riskmanagement #qms
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We are continuing our Employee Spotlight series Razan Barakat, Business Development Specialist at GMED! In her role, Razan focuses on creating and building strong client relationships while identifying opportunities that drive and sustain GMED’s growth. She manages prospect inquiries, develops tailored quotes and services packages to meet customer needs, and guides clients through the signing process to ensure successful certification and new business acquisition. Stay tuned for more stories from our dedicated professionals about their passion for client safety! #TeamSpotlight #LifeatGMED #InnovationInHealthcare
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GMED will be at MedFIT Event from December 3 to 4 at Lille at stand E32. On December 3 from 11.15 am to 12.30 pm, Nabil RIAHI, Sales Director, will be taking part in a discussion on how to use #MDR and #IVDR to develop the right products efficiently. To meet us, please contact [email protected] or via the contact form: https://lnkd.in/dFSyz6pe For more information : https://lnkd.in/emSi4u4q
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Guide MDCG 2024-13: Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices The MDCG has published a guide concerning the qualification of ethylene oxide (EtO) which led to the update of the guide MDCG 2022-5. The coordination group clarifies the regulatory status of EtO depending on the life cycle stage when the device is being sterilized. EtO falls within the scope of Regulations (EU) 2017/745 and 2017/746 as a device or accessory of a device in the case where the device is intended to be sterilized by its end user. EtO will therefore be subject to a conformity assessment in its own right. Eto, on the other hand, is not considered as such if the device is sterilized during the manufacturing process, before being placed on the market: “Its use is controlled as part of the sterilization and validation processes of the manufacturer.” #MDR #IVDR #MDCG #ethyleneoxide #regulation #regulatory
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Walk the MDR Certification path with GMED! Looking to market your orthopedic devices? GMED supports you throughout their MDR certification. GMED, a reference notified body, has one of the most comprehensive designation perimeters on the market, including active and non-active orthopedic codes. Our experts will guide you through the MDR compliance process. Whether your device is new or already on the market, whether you represent an SME or a multinational, GMED has a dedicated team ready to respond to your specific needs. Let’s elevate your orthopedic devices to be compliant and market-ready! Contact us at [email protected] or https://lnkd.in/dNJfZwAi. hashtag #MedicalDevices #Orthopedics #MDR #Compliance
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Discover the November edition of our GMED Highlights format! Each month, we give you an overview of our latest news and upcoming ones: events, newsletters, training sessions, and more. Discover this new publication:? https://lnkd.in/gWW-K-8s
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We're excited to kick off our Employee Spotlight series with Rifka Herman, Service Processing Department Manager at GMED! In this biweekly series, we'll be sharing insights from out talented team members. In her role, Rifka works with a diligent team of Certification Coordinators, creating and distributing pre and post service deliverables to clients. She also collaborates with other departments to ensure timeliness and quality within GMED's processes. Stay tuned for more stories from our dedicated professionals about their passion for client safety!?#TeamSpotlight #LifeatGMED?#InnovationInHealthcare
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Newsletter: "AI Act": What requirements and deadlines for medical devices? On July 12, 2024, Regulation (EU) 2024/1689 was published in the Official Journal of the European Union. This “Regulation on Artificial Intelligence” or “AI Act” marks a new stage in the certification of medical devices (MDs) using this technology. In this latest edition, Damien Barles, MD Project Manager – Artificial Intelligence, details the requirements and transitional provisions relating to this regulation. Download the newsletter: https://lnkd.in/eNivy3X4 To subscribe: https://lnkd.in/dX3GCzw #newsletter #IAact #artificialintelligence
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