Infrastructure The organisation shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:— (a) buildings, workspace and associated utilities, (b) process equipment (both hardware and software), and (c) supporting services (such as transport or communication). The manufacturer shall establish documented r ...

Note: Configuration management is a means by which identification and traceability can be maintained. 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices In defining the records required for traceability, the manufacturer shall include records of all components, materials and work environment conditions, if these could cause the medical dev ...