ISO for Medical Devices

ISO for Medical Devices from LNE G-MED, Notified Body for Medical Devices

By: LNE G-MED, Notified Body for Medical Devices  06/24/2016
Keywords: Iso 9001, Iso 14001, Iso Standards

The International Organization for Standardization (ISO) develops standards that help companies monitor and improve their processes and products, in terms of Quality, Environment, Impact, Safety, Reliability, Efficiency and Interchangeability. Recognized worldwide by Regulatory Affairs Professionals and Quality Managers, ISO bridges the national standards institutes of 159 countries. A company that demonstrates adherence to specific standards can earn credibility with its customers, investors, employees and other stakeholders. In addition, many countries mandate certain ISO certifications prior to granting a manufacturer approval to sell products. Demonstrate Adherence to World Standards through Independent Certification Regulators rely on the work of accredited third parties to audit companies to ISO standards. LNE/G-MED is authorized to certify a variety of ISO standards, including: ISO 9001 Quality Management Systems ISO 13485 - NF EN ISO 13485 Medical Devices, Quality management systems, Requirements for Regulatory Purposes ISO 13485 in combination with sterilization standards - Quality certification of sterilization processes ISO 14001 Environmental management systems, Requirements with guidance for use OHSAS 18001 – Occupational Health and Safety Management Systems ISO 27001 - Information security management ISO 15378 Primary packaging materials for medicinal products, Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

Keywords: ISO 13485, Iso 14001, Iso 9001, Iso Standards, Iso Training

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Other products and services from LNE G-MED, Notified Body for Medical Devices

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Medical Devices Regulations

LNE was established in France in 1901. We serve the medical device industry worldwide. LNE/G-MED is one of the Leading European Notified Bodies and a single-source provider of Voluntary and Regulatory certifications.

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CE marking

Gain market access to Europe! Before you can offer your medical products to nations within the European Union (EU) and the European Free Trade Association, you must first satisfy the requirements for CE Marking, a conformity mark that signifies a product has met all criteria of the relevant EU directives, especially in the areas of Safety and Performance.

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LNE/G-MED America offers a variety of training courses focused on regulatory and quality in the manufacture of medical devices. Our goal is to provide clear, practical "take-home” value to deliver practical impact at your company right away. All of our trainings feature limited class size (10 - 20 attendees) to ensure a high level of interaction, with practical, hands-on practical case studies to encourage material retention and application.

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One of Europe’s Largest Testing Facility. Offer a complete range of standardized tests or customize tests for characterization. Electromagnetic Compatibility (EMC), Electrical Safety, CB Scheme, Charpy reference specimens.

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Product Certification and Quality Management System (QMS) services. A complete certification package to save you the time and costs. CE mark, Active Implantable Medicale Devices, In Vitro Diagnostics, Single Audit Program, ISO 13485, ISO 9001.