Category
Technical Specification
Organisation
Type
Standard
Access
Fees apply to access
Status
Active
Created
January 2025
This document establishes requirements and gives guidance on assurance case framework for healthcare delivery organisations (HDOs) and for health software and medical device manufacturers (MDMs) and can be used to support the communication and information transfer between all parties.
Access Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance and requirements for the use of assurance cases for safety and security
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