Articles tagged with “post-market-surveillance”

MHRA AI Airlock Phase 2: Seven AIaMD Evidence Case Studies

A 2026 analysis of MHRA AI Airlock Phase 2's seven cases, mapping intended purpose, AI-IVD validation, PCCPs and post-market evidence to practical UK development and NHS deployment decisions.

24 min read

10/13/2026

mhra ai airlock phase 2 aiamd ai medical devices regulatory sandbox clinical validation predetermined change control plans post-market surveillance digital pathology uk medical device regulation

Pharma Complaint Management: FDA 21 CFR, EU GVP & CAPA

Review pharma product complaint management regulations, including FDA 21 CFR 211.198 and EU GVP. Analyze CAPA linkage, reporting requirements, and eQMS tools.

40 min read

5/17/2026

pharma complaint management 21 cfr 211.198 21 cfr 820.198 eu gvp capa process pharmacovigilance post-market surveillance eqms software quality assurance

AI SaMD Clinical Evidence: Real-World Performance Studies

Examine clinical evidence generation for AI diagnostic SaMD. This report covers real-world performance studies, FDA guidelines, and post-market surveillance.

40 min read

4/14/2026

samd ai diagnostics clinical evidence real-world evidence post-market surveillance fda guidance performance drift medical software

AI Post-Market Surveillance: Locked vs. Continuous Learning

Compare post-market surveillance for locked vs. continuous learning AI devices. Analyze regulatory guidelines, algorithmic drift, and validation strategies.

60 min read

2/25/2026

post-market surveillance ai medical devices continuous learning locked algorithms algorithmic drift fda regulation samd medical device validation machine learning