Comparing US FDA vs EU MDR Medical Device Software Requirements
Explore the differences in medical device software regulations between the EU’s MDR and the US FDA, including SaMD, SiMD, and cybersecurity guidance.
Month: August 2024
Bioburden Testing vs. Sterility Testing: What Is The Difference?
Bioburden testing quantifies living microorganisms on medical devices pre-sterilization, while sterility testing confirms their absence post-sterilization. Both are vital for patient safety and product efficacy.