Medical Device Insights
Articles on compliant medical software
Practical insights on UX, development, and regulations for medical devices.
Explore our latest
Navigating the Waters of Risk Management for Medical Devices
April 8, 2026
Risk management in medical devices goes beyond compliance — it’s a continuous process of identifying, controlling, and monitoring risks throughout the product l
The how and the what of external software components (SOUP or OTS software) in medical devices
March 25, 2026
How SOUP and OTS software are defined in medical devices — and why documentation effort increases significantly with higher risk levels.
The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)
March 25, 2026
Strict medical software regulations are slowing down updates and innovation — especially for widely used open-source components.
Reliability in medical devices
March 24, 2026
What reliability really means in medical devices—and why it goes beyond trust, safety, quality, and regulation. A clear breakdown of how reliable systems are defined and evaluated in practice.