Most articles in this blogs are meant to explore the topic of agile software development for medical devices in a systematic way. Here’s the table of contents I’m following. Articles without links are unpublished yet.

Quality

• Handling regulations
• Regulatory Quality and Product Quality
• Handling quality-related records in practice
• What about SOUPs?

Project & iteration management

• Agile system building
• The two-phase iteration
• Putting bugs under control
• Project pace regulation

Specification

• Agile specification for medical devices

Architecture

• Process hints for architecting safe medical devices
• Architectural ideas worth considering
• Guidelines for building a culture that promotes good architecture

Testing

• Overview
• Automated tests that can run in the build
• Automated tests that require human supervision
• On manual tests