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.

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

Establish patterns for unit tests that verify software units against requirements with safety-class-appropriate rigor.

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

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

Define structure and content for test plans, protocols, and reports that support regulatory submissions and internal verification.

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

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.

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

Implement identification, change control, and status accounting for software configuration items per IEC 62304:2006+A1:2015, Clause 8—ensuring reproducible baselines, controlled SOUP records, and retrievable history separate from change-request workflow details in `DOC-CHANGE-CONTROL`.

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.

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.

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

Provide actionable guidance to implement IEC 62304:2006+A1:2015 lifecycle processes—development, maintenance, software risk management, configuration management, and problem resolution—with rigor scaled by safety class (A/B/C). This hub skill indexes clause obligations; load child skills for depth.

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

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

Validate interactions between software components and hardware interfaces, ensuring interfaces, protocols, and data flows behave correctly in realistic configurations.

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.

Address **machine learning inside the regulated product** (not LLM coding assistants): **Good Machine Learning Practice (GMLP)**, training/validation data integrity, **Predetermined Change Control Plans (PCCP)** where applicable, drift monitoring, and linking models to ISO 14971 and software lifecycle controls.

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

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

Guide secure, reliable BLE implementation for medical devices handling PHI/therapy control: services, pairing/bonding, LE Secure Connections, privacy, and performance.