Cleanliness of Newly Manufactured Medical Devices

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.

Cleanliness of Newly Manufactured Medical Devices; 1.5 Training Session, Virtual Training; May 5-6, 2026

Schedule (all times EST)<ul><li>Day 1: 9:00am - 5:00pm </li><li>Day 2: 9:00am - 1:00pm </li></ul>About the training Cleaning is often a critical step in the manufacturing process of single-use medical devices as contaminants could cause serious safety problems as well as impact device biocompatibility and sterilization effectiveness. It is the responsibility of the medical device manufacturer to ensure physical, chemical and microbiological contaminants (as applicable) are reduced to a safe level and to provide objective evidence of the verification of the cleaning process effectiveness.   Implementing an effective cleaning process on medical devices requires knowledge on the cleaning technologies available, process design, risk management, test methods, cleanliness requirements, process validation, and process verification. These topics will be covered in this 1.5-day comprehensive course with a focus on NF ISO 19227:2018.    REQUIRED LEVEL<ul><li>Some familiarity with process validation (such as OQ/PQs) and general knowledge of medical devices manufacturing. </li></ul> To learn more about the program, <a href="https://lne-gmed.com/training/cleanliness-newly-manufactured-md" title="https://lne-gmed.com/training/cleanliness-newly-manufactured-md" target="_blank" data-msys-clicktrack="0" rel="nofollow noopener noreferrer">click here</a>.

European in Vitro Diagnostic Devices Regulation (EU) 2017/746

Risk Management Applied to Medical Devices (ISO 14971:2019)

European Medical Device Regulation (EU) 2017/745

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

Technical Documentation per (EU) Medical Device Regulation 2017/745

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Cleanliness of Newly Manufactured Medical Devices

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European in Vitro Diagnostic Devices Regulation (EU) 2017/746

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Cleanliness of Newly Manufactured Medical Devices

More events from GMED North America, Inc.

Discover more events from GMED North America, Inc., from Science & Tech to other experiences you might love.

European in Vitro Diagnostic Devices Regulation (EU) 2017/746

Risk Management Applied to Medical Devices (ISO 14971:2019)

European Medical Device Regulation (EU) 2017/745

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

Technical Documentation per (EU) Medical Device Regulation 2017/745

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