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 7 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 9 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 9 months ago

Sep 29, 2025

The Ultimate Comparison: ISO 13485 vs. FDA 21 CFR

Manufacturers of medical devices need to set up a quality management system (QMS). However, the details of this set of SOPs and templates vary between the...

FDA Compliance Sebastian Skorka Updated about 1 year ago

May 21, 2025