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LNE-GMED UK, newly designated as an Approved Body under UK Medical Device Regulations

Previously designated as an Approved Body for non-medical regulations since October 2022, LNE-GMED UK, a GMED subsidiary of the LNE Group, has expanded its services to medical devices since January 2024 and can now offer certification services in this field.

Previously designated as an Approved Body for non-medical regulations since October 2022, LNE-GMED UK, a GMED subsidiary of the LNE Group, has expanded its services to medical devices since January 2024 and can now offer certification services in this field.

To support manufacturers in accessing the UK market with their products, LNE-GMED UK has implemented optimized processes. Transfers can also be made as part of regulatory certifications (CE and UKCA markings) and voluntary certifications (ISO 13485:2016, MDSAP Program).

By expanding its scope, LNE-GMED UK ensures access to safe and high-performance devices in the UK. This approach confirms the ambitions of GMED and its subsidiaries to serve the healthcare industry on a large scale and support innovation while enhancing patient safety.

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