Medical Device Skills skills

Define what and how to log for medical devices: security/safety events, integrity, protection, and retention of logs for compliance and forensics.

Define architectural partitioning to contain failures, simplify verification, and align safety classes with appropriate isolation.

Ensure integrity of data in storage and transmission using checksums/CRCs/ECC, validation, and redundancy where needed for medical devices.

Guide creation and maintenance of Software Architecture (SAD) and Design Descriptions (SDD) that support safety, traceability, and compliance.

Ensure deterministic and safe memory usage: static allocation, pools, stack sizing, MPU usage, and corruption detection for medical device firmware.

Define C coding practices aligned with MISRA C and medical device safety needs: type safety, control flow, memory management, interrupts, and static analysis.

Apply IEC 62443 concepts (secure development lifecycle, component requirements, security levels) to networked medical devices, ensuring threat-aware design, implementation, and verification of cybersecurity controls.

Secure and robust WiFi connectivity for medical devices: WPA3/enterprise auth, certificate management, coexistence, resilience, and hospital network integration.

Provide conventions for code comments that support traceability to requirements, risks, and tests, while maintaining clarity and brevity.

Provide patterns for detecting, containing, and recovering from faults in medical device software, scaled to safety class.

Define explicit, testable state machines with safe states, controlled transitions, and error handling suited to medical device safety classes.

Define controlled change-request workflow for software: impact analysis, approvals, verification scope, and regulatory submission flags. Configuration identification and baselines are in `DOC-SCM` (IEC 62304 Clause 8.1, 8.3); approved implementation and re-verification align with 8.2.

Define safe interrupt design: short ISRs, deferred work, priority assignment, critical section management, and testing strategies.

Define safe power management patterns: sleep modes, wake sources, power budget, battery monitoring, graceful shutdown, and data preservation.

Define regulated-friendly CI/CD pipelines with compliance checks, artifact management, and auditability for medical device software.

Guide **Software as a Medical Device (SaMD)** and **software in devices** for **clinical evaluation** expectations: intended use, SaMD category (IMDRF framework), evidence of **analytical and clinical validity** where applicable, and alignment with **EU MDR Annex XIV** clinical evaluation and **FDA** premarket clinical/benefit-risk expectations for software-driven diagnostics and monitoring.

Identify, prioritize, and mitigate security threats for medical devices, integrating with risk management and informing control selection.

Ensure bidirectional traceability between requirements, hazards/risks, design, code, tests, and anomalies for medical device software.

Provide actionable guidance for software under EU MDR, focusing on classification (Rule 11), technical documentation expectations, UDI for software, PMS/PMCF needs, and alignment with MDCG guidance.

Uncover robustness and security issues by fuzzing inputs/protocols relevant to medical devices (parsers, IPC, network/BLE/USB).

Provide concise, high-value inline documentation practices (comments and short docblocks) that improve safety, maintainability, and traceability without cluttering code.

Validate software with real or representative hardware, sensors, actuators, and timing, to uncover integration and safety issues not visible in simulation.

Use static analysis (SAST) to detect defects and nonconformities (MISRA, CERT) early, with triage and traceability appropriate to safety class.

Provide implementation guidance for electronic records/signatures (ER/ES) compliance: access control, audit trails, data integrity, and validation expectations in medical device software and supporting tools.