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ISO 9001:2008- Quality Management System

iso 13485 certification processThis standard specifies a set of procedures to demonstrate commitment to quality and ensure continual improvement and customer satisfaction.

Utilized by regulatory affairs professionals and quality managers throughout the world, ISO 9001: 2008 is applicable to all type of companies (manufacturers, services providers…) and industries.

ISO 9001 and its four goals

  • Enhance your company’s image and satisfy your customers
  • Demonstrate the efficiency of all your processes
  • Develop a quality organization focused on customer satisfaction
  • Increase staff involvement in your company’s objectives

The standard covers five main aspects:

  • Quality Management Systems
  • Management's Responsibility
  • Resource Management
  • Product Realization
  • Measurement analysis and continuous improvement

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MDSAP Prepare the transition, worldwide market access

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States


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Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

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