$247 — Standard Tier

SaMD Toolkit: IEC 62304 Software Lifecycle & Cybersecurity

Complete SaMD toolkit with IEC 62304 software lifecycle, SOUP management, cybersecurity documentation, and FDA SaMD guidance implementation templates.

Get the Toolkit — $247

7-day money-back guarantee • One-time purchase • Instant download

What's Included

Software Development Plan Template
Software Requirements Specification Template
Software Architecture Document Template
SOUP List & Risk Assessment
Software Verification Plan & Report
Software Validation Plan & Report
Cybersecurity Risk Assessment Template
SBOM (Software Bill of Materials) Template
SaMD Classification Worksheet

Benefits

IEC 62304 compliant software lifecycle documentation
FDA cybersecurity guidance implementation
SOUP management that satisfies auditors
Clear SaMD classification methodology

Is This For You?

This toolkit is designed for teams facing these challenges:

Software documentation doesn't meet IEC 62304
SOUP list is incomplete or missing
Cybersecurity requirements are unclear
FDA rejected submission for software deficiencies

Who This Is For

Software teams at medical device companiesSaMD startups building first productRA professionals new to software regulations

Frequently Asked Questions

What safety class should my software be?

Worksheet helps determine Class A, B, or C based on IEC 62304 criteria.

Does this cover AI/ML medical devices?

Includes FDA AI/ML guidance considerations. Rapidly evolving area - check latest FDA guidance.

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Ready to Get Started?

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

Get the Toolkit — $247

7-day money-back guarantee