Medical Device Software Blog

Practical guides for FDA compliance, IEC 62304 implementation, and 510(k) documentation — written by people who've done it.

Latest articles
FDA Compliance
FDA 510(k) Software Documentation: What You Actually Need to Submit
Every document FDA expects for a software-based 510(k) — SRS, SSTC, SSTP, traceability matrix — and the gaps that trigger Additional Information letters.
May 2026 · 12 min read Read →
Standards
IEC 62304 Explained: A Practical Guide for Medical Device Startups
The international standard for medical device software lifecycle — the three safety classes, what each requires, and how to achieve compliance without drowning in process.
May 2026 · 10 min read Read →
Documentation
Medical Device Traceability Matrix: Structure, Template, and Common Mistakes
What a compliant traceability matrix must contain, a template column structure, and the coverage requirements that FDA reviewers actually check.
May 2026 · 9 min read Read →
Coming soon
ISO 14971 Risk Management for Software: A Practical Implementation Guide
How to apply ISO 14971 to software systems — hazard identification, risk controls, and connecting your risk file to the SRS.
Coming soon
21 CFR Part 11: Electronic Signatures and Records for Medical Device Software
What Part 11 requires for electronic records, audit trails, and e-signatures — and how to avoid the most common compliance gaps.
Coming soon
Design History File vs. Device Master Record: What Goes Where
21 CFR Part 820 requires both a DHF and a DMR. This guide explains the difference, what belongs in each, and how to maintain them through product iterations.