Software Documentation Requirements for Medical Devices in the United States
Guidance and best practices for 2025 FDA expectations. Learn what documentation the FDA requires for software in or as a medical device, how to structure your lifecycle evidence, and how consulting helps you avoid delays.
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Software documentation consulting for device manufacturers in 2025. This guide explains the FDA’s 2023 software guidance, required documents, and strategies to build compliant, traceable, and audit-ready software files—aligned with ISO 13485, IEC 62304, and ISO 14971.
Contents
1 — What you’ll learn
- What documentation the FDA expects for software in or as a medical device in 2025.
- How to structure lifecycle evidence for ISO 13485, IEC 62304, and ISO 14971 alignment.
- How to avoid submission delays and inspection findings with strong traceability.
- Where a focused consulting review reduces risk, cost, and rework.
2 — Who this guide is for
Engineering, quality, clinical, and regulatory leads building devices with embedded software, connected accessories, companion apps, or SaMD destined for U.S. FDA review.
3 — FDA framework and scope
- Current guidance (June 14, 2023): Content of Premarket Submissions for Device Software Functions (replaces 2005 guidance).
- Scope: Software functions meeting FD&C Act §201(h) are in-scope.
- Risk-based oversight: May require 510(k), De Novo, or PMA; some functions may fall under enforcement discretion.
- Global context: IMDRF SaMD principles inform harmonization and multi-region readiness.
Quick win: Draft a one-page “Regulatory Position” (device description, software functions, intended use, expected documentation level) and circulate for alignment.
4 — Core documentation elements
Software Requirements Specification (SRS)
- Define functions, interfaces, data I/O, performance, safety, cybersecurity, error handling.
- For SaMD/connected devices, capture clinical context and usability constraints.
Software Design Specification (SDS)
- Architecture, modules, interfaces, data structures, algorithms, HW/SW mapping.
- Maintain end-to-end traceability from requirements to tests.
Verification & Validation (V&V)
- Verification: unit/integration tests, code reviews, static analysis.
- Validation: usability and, when applicable, clinical performance.
- Plans, protocols, reports, and coverage metrics with explicit acceptance criteria.
Risk Management
- Hazards → hazardous situations → software causes/mitigations; residual risk rationale (ISO 14971).
- Link risk controls to design and test evidence.
Traceability Matrix
- Map user needs → SRS → design → tests → risk controls for auditability.
Configuration & Change Control
- Versioning, build environment, baselines, release notes, and change history.
Maintenance & Decommissioning
- Update/patch strategy, regression validation, user communications, end-of-life plan.
Cybersecurity (as applicable)
- Threat modeling, SBOM/OTS inventory, vulnerability handling, secure SDLC evidence.
Usability / Human Factors
- Formative and, when warranted, summative validation of critical tasks.
5 — Documentation levels: Basic vs Enhanced
- Basic: Failure unlikely to cause serious injury/death. Solid design control, V&V, risk management with lighter evidence.
- Enhanced: Failure could present hazardous situations with probable risk of serious injury/death. Requires deeper process evidence, independent verification, robustness testing, architectural and threat/failure analyses.
6 — Best-practice roadmap
- Start documentation alongside design/development.
- Apply IEC 62304 (lifecycle), IEC 62366 (usability), ISO 14971 (risk).
- Keep a live traceability matrix and version control.
- Account for third-party/OTS components with full versioning and support details.
- Plan update validation and user notification workflows.
- Write submission-ready summaries—even if exempt.
- Structure files for fast retrieval during audits.
7 — How consulting accelerates compliance
A seasoned partner reduces cost and risk by front-loading the right decisions.
- Right-sized SRS/SDS/V&V templates and risk controls aligned to your class and pathway.
- Cybersecurity and usability documentation tuned to FDA expectations.
- Traceability matrices and submission formatting that minimize AI cycles.
8 — FAQs
- Do all software devices require Enhanced Documentation?
- No. Many accessories and monitoring tools qualify for Basic Documentation; the level depends on potential harm from failure.
- Is IEC 62304 mandatory for U.S. submissions?
- Not strictly required by law, but widely used to demonstrate software lifecycle control to the FDA.
- Can we recover if development started without documents?
- Yes—perform a retrospective gap analysis, rebuild missing traceability, and validate updates prospectively.
Work With Pulse Axis
From template kits to full build-outs (SRS/SDS/V&V, risk, traceability), we tailor support to your device and timeline.