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ISO 13485 - Quality certification of sterilization processes

iso 13485 registration medical devicesFor manufacturers performing sterilization and hospital service providers, LNE/G-MED offers QMS certification completed by the following standards:

  • NF EN ISO 11135-1: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • EN ISO 11137-2: Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
  • EN ISO 11137-3: Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
  • EN 17665-1: Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

This certification provides customers and competent authorities with quality assurance of a controlled sterilization process for a specific activity.

Iso 13485 sterilization certification process To request a proposal, contact us.

combo ISO 13485 9001

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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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