Medical Device Skills skills

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

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

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

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.

Ensure OTA updates are authenticated, integrity-checked, atomic, and safely recoverable, with regulatory considerations for software changes.

Define how to automate tests (unit, integration, system/HIL where feasible) in CI/CD pipelines for medical devices with gating and evidence capture.

Provide patterns for HAL design that enable testability, portability, and safety: clear interfaces, separation from application logic, and mockability.

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

Guide use of the legacy software pathway (IEC 62304:2006+A1:2015, 4.4) when device software was legally marketed before full lifecycle evidence existed—balancing continued use with gap analysis, risk management, and targeted closure activities instead of re-running all of Clauses 5–9 from scratch.

Define controlled release process for medical device software: versioning, branching, verification, approvals, documentation, and post-release monitoring.

Provide safe RTOS usage patterns: task design, priorities, IPC, deadlines, priority inversion avoidance, and timing analysis for medical devices.

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

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

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

Define secure user/device authentication, session management, and RBAC suitable for medical device risk profiles.

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.

Detect runtime defects (memory, concurrency, timing, performance, power) via dynamic tools and instrumentation in medical device software.

Enable safe and standards-aligned interoperability: HL7 FHIR/IHE profiles, data formats, terminology mapping, and API design for medical data exchange.

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

Implement safe USB device connectivity: class selection, enumeration handling, data validation, electrical and safety considerations.

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

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

Identify and handle PHI in software to enforce minimum necessary use, encryption, access control, and retention/deletion policies.

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.