LNE-GMED UK, GMED subsidiary of the LNE group, has extended its accreditation by UKAS under ISO/IEC 17021-1:2015 for quality management system certification activities to ISO 13485:2016 in the field of medical devices and healthcare. The new technical areas include IVDs and parts or services.
The current technical areas now within the accreditation scope are:
1.1 Non-active Medical Devices
1.2 Active Medical Devices (non-implantable)
1.4 In Vitro Diagnostic Medical Devices (IVDs)
1.5 Sterilization Method for Medical Devices
1.6 Devices incorporating/Utilizing Specific Substances/ Technologies
1.7 Parts or services
This schedule is available on the UKAS website.
This extension is a significant first step for LNE-GMED UK towards its IVD UK Approved Body (UKAB) designation in the coming weeks.
In the meantime, LNE-GMED UK continues to be mobilised towards extending its scope of accreditation to include active implantable medical devices.
Its teams are available to support any UK certification project in the frame of its accreditations through the following email address contact UKenquiries@lne-gmed.com
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