meddev-agent-skills

In the author's own words, from each skill's SKILL.md — showing the first 30 of 59 files.

• meddev-21-cfr-part-11

  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. Use when working on 21 cfr part 11 in medical device software.

  skills/meddev-21-cfr-part-11/SKILL.md on GitHub (opens in a new tab)

• meddev-ai-assisted-development-governance

  Define governance for AI/LLM-assisted software development (e.g., Cursor, Copilot, Claude): human review expectations, evidence that generated code is covered by requirements-based tests, tool validation for GxP-adjacent workflows, and alignment with Computer Software Assurance (CSA) principles (risk-based, critical thinking) without replacing your SOPs. Use when working on ai assisted developmen…

  skills/meddev-ai-assisted-development-governance/SKILL.md on GitHub (opens in a new tab)

• meddev-ai-ml-medical-device-software

  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. Use when working on ai ml medical device software in medical device software.

  skills/meddev-ai-ml-medical-device-software/SKILL.md on GitHub (opens in a new tab)

• meddev-audit-logging

  Define what and how to log for medical devices: security/safety events, integrity, protection, and retention of logs for compliance and forensics. Use when working on audit logging in medical device software.

  skills/meddev-audit-logging/SKILL.md on GitHub (opens in a new tab)

• meddev-authentication

  Define secure user/device authentication, session management, and RBAC suitable for medical device risk profiles. Use when working on authentication in medical device software.

  skills/meddev-authentication/SKILL.md on GitHub (opens in a new tab)

• meddev-automated-testing

  Define how to automate tests (unit, integration, system/HIL where feasible) in CI/CD pipelines for medical devices with gating and evidence capture. Use when working on automated testing in medical device software.

  skills/meddev-automated-testing/SKILL.md on GitHub (opens in a new tab)

• meddev-ble-medical

  Guide secure, reliable BLE implementation for medical devices handling PHI/therapy control: services, pairing/bonding, LE Secure Connections, privacy, and performance. Use when working on ble medical in medical device software.

  skills/meddev-ble-medical/SKILL.md on GitHub (opens in a new tab)

• meddev-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. Use when working on change control in medical device software.

  skills/meddev-change-control/SKILL.md on GitHub (opens in a new tab)

• meddev-code-comments

  Provide conventions for code comments that support traceability to requirements, risks, and tests, while maintaining clarity and brevity. Use when working on code comments in medical device software.

  skills/meddev-code-comments/SKILL.md on GitHub (opens in a new tab)

• meddev-code-coverage

  Measure and enforce coverage appropriate to safety class: statement/branch and MC/DC where applicable, with documented exclusions. Use when working on code coverage in medical device software.

  skills/meddev-code-coverage/SKILL.md on GitHub (opens in a new tab)

• meddev-data-integrity

  Ensure integrity of data in storage and transmission using checksums/CRCs/ECC, validation, and redundancy where needed for medical devices. Use when working on data integrity in medical device software.

  skills/meddev-data-integrity/SKILL.md on GitHub (opens in a new tab)

• meddev-defensive-design

  Apply defensive coding techniques to prevent, detect, and safely handle abnormal conditions in safety-relevant software. Use when working on defensive design in medical device software.

  skills/meddev-defensive-design/SKILL.md on GitHub (opens in a new tab)

• meddev-design-docs

  Guide creation and maintenance of Software Architecture (SAD) and Design Descriptions (SDD) that support safety, traceability, and compliance. Use when working on design docs in medical device software.

  skills/meddev-design-docs/SKILL.md on GitHub (opens in a new tab)

• meddev-dynamic-analysis

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

  skills/meddev-dynamic-analysis/SKILL.md on GitHub (opens in a new tab)

• meddev-embedded-c

  Define C coding practices aligned with MISRA C and medical device safety needs: type safety, control flow, memory management, interrupts, and static analysis. Use when working on embedded c in medical device software.

  skills/meddev-embedded-c/SKILL.md on GitHub (opens in a new tab)

• meddev-embedded-cpp

  Define a constrained C++ subset suitable for medical device firmware, aligned to MISRA C++ guidance: safe types, RAII, limited dynamic features, and predictable behavior. Use when working on embedded cpp in medical device software.

  skills/meddev-embedded-cpp/SKILL.md on GitHub (opens in a new tab)

• meddev-encryption

  Guide selection and use of cryptography for medical devices: algorithms, key derivation, data at rest/in transit, library choice, and FIPS considerations. Use when working on encryption in medical device software.

  skills/meddev-encryption/SKILL.md on GitHub (opens in a new tab)

• meddev-eu-mdr

  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. Use when working on eu mdr in medical device software.

  skills/meddev-eu-mdr/SKILL.md on GitHub (opens in a new tab)

• meddev-fault-tolerance

  Provide patterns for detecting, containing, and recovering from faults in medical device software, scaled to safety class. Use when working on fault tolerance in medical device software.

  skills/meddev-fault-tolerance/SKILL.md on GitHub (opens in a new tab)

• meddev-fda-820-design-controls

  Map 21 CFR Part 820 Subpart C — Design Controls to software lifecycle work: design planning, inputs, outputs, review, verification, validation, transfer, and DHF/DMR links, including how software validation (intended use / risk controls) complements verification (requirements and specs). Includes a concise ISO 13485:2016 slice where it overlaps QMS expectations for design and risk (interpretation…

  skills/meddev-fda-820-design-controls/SKILL.md on GitHub (opens in a new tab)

• meddev-fda-premarket

  Guide preparation of FDA premarket submission software documentation (510(k), De Novo, PMA), including documentation depth determination, required documents, cybersecurity, SBOM, interoperability, and post-market commitments. Use when working on fda premarket in medical device software.

  skills/meddev-fda-premarket/SKILL.md on GitHub (opens in a new tab)

• meddev-fuzz-testing

  Uncover robustness and security issues by fuzzing inputs/protocols relevant to medical devices (parsers, IPC, network/BLE/USB). Use when working on fuzz testing in medical device software.

  skills/meddev-fuzz-testing/SKILL.md on GitHub (opens in a new tab)

• meddev-hardware-abstraction

  Provide patterns for HAL design that enable testability, portability, and safety: clear interfaces, separation from application logic, and mockability. Use when working on hardware abstraction in medical device software.

  skills/meddev-hardware-abstraction/SKILL.md on GitHub (opens in a new tab)

• meddev-hardware-in-loop

  Validate software with real or representative hardware, sensors, actuators, and timing, to uncover integration and safety issues not visible in simulation. Use when working on hardware in loop in medical device software.

  skills/meddev-hardware-in-loop/SKILL.md on GitHub (opens in a new tab)

• meddev-iec-62304-legacy-software

  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. Use when working on iec 62304 legacy software in medical device software.

  skills/meddev-iec-62304-legacy-software/SKILL.md on GitHub (opens in a new tab)

• meddev-iec-62304-software-risk

  Guide implementation of the software-specific risk management process (IEC 62304:2006+A1:2015, Clause 7) alongside ISO 14971:2019—identifying how software items contribute to hazardous situations, defining and verifying software risk controls, and re-analysing risk when software changes. Use when working on iec 62304 software risk in medical device software.

  skills/meddev-iec-62304-software-risk/SKILL.md on GitHub (opens in a new tab)

• meddev-iec-62304

  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. Use when working on iec 62304 in medical device software.

  skills/meddev-iec-62304/SKILL.md on GitHub (opens in a new tab)

• meddev-iec-62366-usability

  Implement IEC 62366-1 usability engineering for software: identify use-related risks, iterate UI with formative evaluation, confirm risk controls with summative testing, and trace results to ISO 14971 and design/verification records. Use when working on iec 62366 usability in medical device software.

  skills/meddev-iec-62366-usability/SKILL.md on GitHub (opens in a new tab)

• meddev-iec-62443

  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. Use when working on iec 62443 in medical device software.

  skills/meddev-iec-62443/SKILL.md on GitHub (opens in a new tab)

• meddev-inline-docs

  Provide concise, high-value inline documentation practices (comments and short docblocks) that improve safety, maintainability, and traceability without cluttering code. Use when working on inline docs in medical device software.

  skills/meddev-inline-docs/SKILL.md on GitHub (opens in a new tab)

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