MedTech & Clinical AI
Documenting SaMD Risk Under ISO 14971 for FDA 510(k)
Learn how software engineering teams map SaMD hazard analysis, risk controls, and residual risk under ISO 14971 for FDA 510(k) submissions.
Medical Device Software
MedTech & Clinical AI
How to certify edge AI cardiac monitors under EU MDR Annex IX
Follow this step-by-step guide to align edge AI cardiac monitors with EU MDR Annex IX technical file and conformity assessment requirements.
MedTech & Clinical AI
Mapping Software Changes to FDA Predetermined Change Plans
Learn how to align algorithmic updates with FDA predetermined change plans to maintain compliance and avoid unnecessary new 510(k) submissions.
MedTech & Clinical AI
Validating Edge AI Cardiac Monitors for EU MDR Compliance
Learn how to validate edge AI cardiac monitors for EU MDR compliance. Cover sensor drift, signal noise, performance testing, and bias mitigation.
MedTech & Clinical AI
Automating Surgical Tray Inspection with Computer Vision
Learn how computer vision surgical tray inspection automates instrument counts and verifies tray configurations before sterilization cycles.
MedTech & Clinical AI
Drafting FDA PCCPs for Adaptive Clinical Algorithms
Learn how to build an FDA predetermined change control plan medical software guide to safely retrain clinical ML models without new 510(k) filings.
MedTech & Clinical AI
FDA 21 CFR Part 11 Impact on Medical Device Software Development
Understand how FDA 21 CFR Part 11 affects medical device software development, validation, and maintenance in ambulatory surgical centers.
mintHealth
The autonomous procurement operating system for ambulatory surgical centers — built by Northhaven.