Practical guides for medical device compliance
QMSR transition, gap analysis, cybersecurity — written for small teams preparing to ship.
The QMSR Transition: What Changed, What Didn’t, and What to Do Now
The FDA’s replacement for 21 CFR Part 820. What it means for your quality system and how to prepare.
QMSR Gap Analysis: A Practical Guide
How to run a clause-by-clause gap analysis of your quality system against ISO 13485 with QMSR overlay.
QMSR Is Now in Enforcement — What It Means for a Small Device Company
The transition period is over. What changed, what FDA can now review during an inspection that it could not review before, and what to have documented today.
Scanning Google Drive for QMSR Compliance Gaps
How to connect your Google Drive and get a requirement-by-requirement compliance review of your quality system.
ISO 14971 Risk Management: What a real risk file looks like
Hazard identification, risk estimation, control, residual risk, and post-production feedback — per ISO 14971:2019 and the companion ISO/TR 24971:2020.
IEC 62304 Software Lifecycle: What a real software file looks like
Safety classification, software development and maintenance processes, risk management, SOUP, and configuration management — per IEC 62304:2015 + Amd 1:2015.
IEC 62366 Usability Engineering: From intended use to summative evaluation
Intended users, hazard-related use scenarios, formative and summative evaluation, and integration with risk management — per IEC 62366-1:2015 and FDA Human Factors guidance.
IEC 81001-5-1 + FDA Cybersecurity Guidance (Updated 2026): What you need to ship
How to determine cyber device scope, build SPDF evidence with a small team, produce the security risk management artifacts, and respond to RTA deficiency letters.