FDA Compliance

FDA Risk Classification for Software as a Medical Device (SaMD)

The Food and Drug Administration (FDA) plays a vital and hands-on role in the United States, ensuring medical devices are safe and effective before they ever...

FDA Compliance Sebastian Skorka Updated 9 months ago

Nov 12, 2025

Design History File (DHF) for SaMD: Your Software's Design Story

Developing Software as a Medical Device (SaMD) is a complex process. Throughout the software development lifecycle – from the initial concept and...

FDA Compliance Sebastian Skorka Updated 11 months ago

Oct 07, 2025

Electronic Case Report Form - FDA vs. MDR

If you're in the medical device field, you know that clinical studies are often essential to prove your device is safe and does what it claims. This is...

FDA Compliance Sebastian Skorka Updated 11 months ago

Sep 29, 2025

ISO 13485 vs. FDA QMSR (21 CFR Part 820): 2026 Comparison

Short answer: ISO 13485:2016 is now the foundation of the FDA's Quality Management System Regulation, but an ISO 13485 certificate is not FDA compliance....

FDA Compliance Sebastian Skorka Updated 4 days ago

Aug 18, 2026