MDSAP Audit Approach (MDSAP AU P0002)
Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

MDSAP Audit Approach (MDSAP AU P0002) C3-T12-CYBER: For devices with software or programmable logic, collect cybersecurity feedback (vulnerability reports, incidents, threat intelligence) after release and feed it into risk management, improvement and design change

What does C3-T12-CYBER require?

Under ISO 13485:2016 clause 8.2.1, post-production feedback for devices with a device software function, software, firmware or programmable logic (whatever their authorization date) should systematically collect vulnerability reports, security incident data and relevant threat intelligence, for example from coordinated vulnerability disclosure, regulator cybersecurity communications, sector information sharing networks and customer reports, and assess new threats for their effect on safety and performance. The organisation has to use this cybersecurity feedback as input to risk management (7.1), improvement (8.5) and design change control (7.3.9).

Maintained by Gerard Blokdyk

Other controls in Chapter 3: Measurement, analysis and improvement – MDSAP Audit Approach (MDSAP AU P0002)

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The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.