Revision 11 of the MDSAP Audit Approach (document number MDSAP AU P0002.011, revision date 3 August 2026), the audit procedure of the Medical Device Single Audit Program in which the regulatory authorities of the United States, Australia, Brazil, Canada and Japan participate. Main changes from version 010: (1) Cybersecurity. Measurement, Analysis and Improvement Task 12 adds provisions on post-market feedback, including systematic collection of vulnerability reports, security incident data and threat intelligence, used as input to risk management, improvement and design change control. Design and Development Tasks 7 and 12 add US FDA cybersecurity requirements, and Task 7 adds RDC ANVISA 848/2024 Article 1 to the Brazilian requirements. For the FDA, auditors verify that cyber devices cleared or approved after 29 March 2023 meet section 524B(b) of the FD&C Act: a plan to monitor and address post-market vulnerabilities including coordinated vulnerability disclosure, processes and post-market patches to keep the device cybersecure, and a maintained software bill of materials. (2) The predetermined change control plan (PCCP) text in Device Marketing Authorization and Facility Registration Task 3 no longer refers specifically to AI-enabled devices. (3) Other changes include refocusing Management Task 7 on management oversight of risk management across the product life cycle, and additions on UDI for Australia (TGA) and the FDA.