envelope  Contact us

phone1-301-495-0477

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 Training ISO13485 MDSAP

Questions?

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

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

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

Training LNE G MED

Combo Training ISO13485 MDSAP

Transition to ISO 13485:2016

& The fundamentals of the Medical Device Single Audit Program (MDSAP) for Medical Device Manufacturers

2 days course 

Click here to Register