$347 — Premium Tier

SaMD Clinical Evaluation Toolkit: AI/ML and Software Medical Device Templates

SaMD Clinical Evaluation Toolkit — IMDRF clinical evaluation plan, algorithm performance protocol, real-world evidence study, intended use determination, PCCP template, and post-market monitoring plan.

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What's Included

SaMD Clinical Evaluation Plan (IMDRF Framework)
SaMD Algorithm Performance Evaluation Protocol
Real-World Evidence (RWE) Study Protocol for SaMD
SaMD Intended Use and Clinical Significance Determination Worksheet
Predetermined Change Control Plan (PCCP) Template
SaMD Post-Market Performance Monitoring Plan

Benefits

Clinical evaluation plan structured per IMDRF N41 tiered evidence framework
Algorithm performance protocol covers AI/ML training/validation/test dataset documentation
PCCP template enables algorithm updates without new 510k for pre-specified changes
Post-market monitoring covers algorithm drift detection and real-world performance tracking

Is This For You?

This toolkit is designed for teams facing these challenges:

FDA requesting additional clinical evidence for SaMD without structured clinical evaluation plan
AI/ML algorithm performance evaluation missing required dataset documentation
No PCCP in place requiring new 510k for each algorithm update
Post-market monitoring not detecting algorithm performance drift in real-world use

Who This Is For

RA leads managing AI/ML SaMD regulatory strategyClinical affairs teams generating real-world evidence for SaMD submissionsProduct teams building PCCP for continuous learning algorithmsDigital health companies preparing FDA 510k or De Novo for SaMD

Frequently Asked Questions

What is the IMDRF SaMD clinical evidence framework?

IMDRF N41 defines tiered evidence based on significance of SaMD output (inform/drive/treat) and state of healthcare situation (critical/serious/non-serious). Higher risk combinations require stronger clinical evidence.

What is a PCCP and when is it required?

A Predetermined Change Control Plan submitted with a 510k describes anticipated future AI/ML modifications. Pre-specified changes can be implemented without a new submission if the PCCP is accepted.

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Ready to Get Started?

Download immediately after purchase. All templates are editable Word and Excel files.

Get the Toolkit — $347

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