Articles tagged with “clinical-validation”

FDA Digitally Derived Measures in Clinical Trials

A 2026 evidence matrix for FDA digitally derived measures, covering endpoint roles, verification, validation, missingness, change control, and a stride-length example.

24 min read

9/19/2026

fda digitally derived measures digital endpoints clinical trials digital biomarkers sensor-based endpoints analytical validation clinical validation digital health technologies change control

FDA Generative AI Medical Device Evidence Matrix

A 2026 analyst guide to FDA's GenAI medical device discussion paper, with a two-axis risk matrix, competency evidence plan, lifecycle monitoring controls, and 30/60/90-day readiness actions.

27 min read

9/19/2026

fda generative ai medical device genai medical device regulation ai-enabled medical devices medical device evidence competency assessment lifecycle monitoring predetermined change control plan samd clinical validation

MedTech AI Quality Benchmark: Validation and PCCPs

A 2026 MedTech AI quality benchmark for clinical validation, PCCP maturity, model traceability, postmarket monitoring, survey methods, and a reproducible FDA appendix.

23 min read

9/19/2026

medtech ai quality benchmark medical device ai clinical validation predetermined change control plan pccp postmarket monitoring model drift model traceability data governance

Clinical Evidence Requirements for AI Diagnostic Tools

Explore clinical evidence requirements for AI diagnostic tools. Covers FDA/EU regulations, prospective vs. retrospective validation, and performance standards.

35 min read

2/8/2026

ai diagnostic tools clinical evidence medical device regulation fda 510(k)clinical validation prospective studies software as a medical device eu mdr