Clinical Validation
Evidence appropriate to intended use, population and clinical context.
TRUST
Trust is not a final compliance layer. It must be designed into the clinical, technical and organizational lifecycle.
Evidence appropriate to intended use, population and clinical context.
Transparency, meaningful human oversight and attention to limitations.
Lifecycle discipline for medical software development and change.
Pathways considered according to intended use and applicable jurisdiction.
Patient information handled with privacy and governance by design.
Security considered throughout architecture, development and operations.
CLEAR STATUS COMMUNICATION
Capabilities should be described according to their actual stage. Research and development concepts must never be presented as authorized medical products.