GMED North America

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

#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

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

#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

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

#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

#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 

#SurveyResult We recently asked for your invaluable opinion on the critical roadblocks you, as an MD manufacturer, face while ensuring regulatory compliance for your medical devices. Your insights are invaluable, and we’re pleased to share the findings: 17% think that there is a lack of available guidance documents to explain the regulations 17% cannot find notified bodies with the capacity to take charge of their projects 25% have difficulty interpreting European regulations relating to MDs/IVDs 42% find it difficult to balance keeping existing medical devices on the market and innovation. At GMED, we are committed to supporting you throughout your compliance process. Our dedicated certification project managers are here to assist you, and we currently have certification slots available to address your requests. We also offer training tailored to the challenges faced by manufacturers in the sector, and provide technical guides. With our expertise, we can cover all IVDs and MDs, regardless of their level of innovation. To find out more, contact us request@lne-gmed.com or https://lnkd.in/dNJfZwAi #MDR #MedicalDevices #Certification #RegulatoryTraining #ComplianceChallenges

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 request@lne-gmed.com or https://lnkd.in/dNJfZwAi. #MedicalDevices #Orthopedics #MDR #Compliance

Let’s meet after summer at RAPS Convergence 2024! Don't miss the opportunity to connect with our experts! Dr. Duncan McPherson, Internal Clinician at LNE-GMED UK, Catherine Holzmann PhD, IVD Department Manager, and Tom Patten, IVDR/IVD International Manager, will participate in different presentations throughout the event. Our experts and business development team will be available at booth 434 to discuss your certification projects and showcase our services. Book a meeting with us now: https://lnkd.in/eN67sizu #RAPSConvergence2024 #RegulatoryProfessionals #MedicalDevices #Healthcare #Networking #Education #MDR #IVDR