Skill UI

Guides medical device teams through preparing ISO 13485:2016 Quality Management System documentation by combining gap analysis, requirements references, templates, and step-by-step creation workflows for manuals, procedures, and compliance artifacts.

A rigorous, multi-phase auditing skill designed for blockchain protocols. It verifies whether the implemented smart contract code strictly adheres to the detailed specifications provided in whitepapers, design documents, or technical specifications. It performs exhaustive, line-by-line semantic analysis to identify gaps, inconsistencies, and deviations across logic, invariants, and security guarantees, making it essential for formal compliance checking in decentralized systems.

Provides comprehensive, end-to-end guidance for establishing and maintaining an Information Security Management System (ISMS) compliant with ISO/IEC 27001:2022. This framework covers critical phases including gap analysis, detailed risk assessment methodology, selecting and documenting Annex A controls, creating the Statement of Applicability (SoA), and preparing for internal and external certification audits.

A comprehensive toolkit for medical device manufacturers seeking ISO 13485 certification. This skill guides users through gap analysis, creating mandatory Quality Management System (QMS) documentation, and ensuring compliance with global medical device regulations (e.g., EU MDR, FDA QMSR). It provides templates, guidance, and structured processes for foundational QMS documents like Quality Manuals and CAPA procedures.

Generates a comprehensive, structured, and blameless incident postmortem document. This skill is designed for Root Cause Analysis (RCA), P1/P2 incident reviews, and outage reports, ensuring the focus remains on systemic gaps and preventative action items rather than individual blame. It guides the user through gathering all necessary details, from the timeline and impact to defining concrete action owners and due dates.

An expert advisor for Australian government entities and their supply chains, specializing in the Australian Defence Signal (ASD) Information Security Manual (ISM). This skill guides users through the entire lifecycle of system security, including Gap Analysis, System Authorisation (ATO), IRAP preparation, and creating mandated security documentation (e.g., SSP). It ensures compliance with risk-based security standards for classified government systems.