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IRIC safety alert

Safety Information Message - SIM2210

Published on 01 September 2022

From: NHSScotland Assure

SIM2210 - IPEM guidance for health institutions on in-house manufacture and use, including software (2nd Ed.)

Documents

Details

The Institute of Physics and Engineering in Medicine (IPEM) has updated its guidance on in-house manufacture and use of medical devices. It provides guidance on what constitutes ‘in-house manufacture and use’ within the same health institution as well as best practice guidance when undertaking these activities.

This document is specifically referenced in para 6.43 of SHTN 00-04 Guidance on Management of Medical Devices and Equipment in Scotland's Health and Social Care Services.