Documentation
Standards, in brief
Short summaries of the standards and regulations I work with on regulated medical software. Each one covers what it is, what it asks for, and what it means for a software project.
Start here
Interactive
Standards map
How the standards, the quality system and the submissions fit together. Pick a block to see what it builds on, or filter by what you are building.
Reference
Glossary
111 terms and abbreviations, from AFAP to vigilance, each with a plain definition and a link to where it matters.
Standards
Standard
IEC 62304
The software life cycle standard for medical device software.
Standard
ISO 13485
The quality management system standard for medical device organisations.
Standard
ISO 14971
The risk management standard for medical devices.
Standard
IEC 60601
The safety standard family for medical electrical equipment.
Regulatory pathways
Regulatory pathway
FDA 510(k)
The most common US route to market for moderate-risk devices.
Regulatory pathway
CE Mark
The route to market in the European Union under the MDR and IVDR.
Practices
Practice
Design Controls
Developing a device under a controlled, documented process.
Practice
V&V & Traceability
Proving the product meets its requirements, and that the requirements were right.
Security & compliance
A summary for orientation. It is not regulatory or legal advice, and it is no substitute for the standard or regulation itself. Requirements change: confirm the current edition before relying on anything here. Last reviewed November 2026.