Technical Documentation per Regulation (EU) 2017/746 (IVDR)

GMED North America. is the subsidiary of GMED, leading Certification Organization & distinguished Notified Body (CE0459).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 № 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.GMED’s success and high level of performance rely first and foremost on a strong and dedicated team of individuals trained at the highest level of the current evaluation and auditing methods to provide the best 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 in your target markets.

GMED North America, Inc.

Technical Documentation per (EU) In Vitro Diagnostic Device Regulation 2017/746;  1.5-Day Sessions; Online Training; November 24-25, 2025

Schedule (all times EST)<ul><li>Day 1: 9:00am - 5:00pm</li><li>Day 2: 9:00am - 1:00pm</li></ul>About the trainingThe European Union Medical In Vitro Diagnostic Device Regulation– Regulation (EU) 2017/746 (or EU IVDR) – entered into force on May 26th, 2017. GMED North America has designed a comprehensive training course to help companies get ready for their application to obtain and/or maintain CE marking for their medical in vitro diagnostic device product(s) and:<ul><li>Gain an understanding of the changes introduced by EU IVDR requirements;</li></ul><ul><li>Assess the impacts of those changes on their organizational and structural activities</li></ul> For program and more information, <a href="https://lne-gmed.com/training/technical-documentation-per-eu-in-vitro-diagnostic-devices-regulation-eu-2017-746" title="https://lne-gmed.com/training/technical-documentation-per-eu-in-vitro-diagnostic-devices-regulation-eu-2017-746" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">click here</a>.

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Technical Documentation per Regulation (EU) 2017/746 (IVDR)

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