Bundle — Save 74%
SaMD & Software Compliance Bundle
IEC 62304, SaMD classification, cybersecurity, 510(k) pathway, and software validation — built for teams developing software as a medical device.
$347$1,435 if bought separately
5 toolkits. One payment. Instant download.
Get the bundle — $347 →Instant download. 30-day refund if not useful.
What's included
✓SaMD IEC 62304 Software Lifecycle Toolkit
$347IEC 62304 compliance plan, software development lifecycle procedures, SOUP management, verification & validation.
✓SaMD Classification & Regulatory Strategy Toolkit
$247SaMD classification decision tool, IMDRF framework mapping, 510(k) vs De Novo pathway guide, regulatory strategy template.
✓Medical Device Cybersecurity Toolkit
$247Cybersecurity risk management plan, threat modeling template, SBOM template, patch management procedure.
✓510k Pathway Determination Toolkit
$347Predicate selection criteria, substantial equivalence analysis template, 510(k) vs PMA decision tree.
✓Software Validation & CSV Toolkit
$247Software validation plan, validation protocol templates, traceability matrix, regression testing guide.
Total value$1,435
Who it's for
→SaMD startups building their regulatory strategy before their first FDA submission
→Software teams at established medical device companies adding SaMD products
→RA consultants helping digital health companies navigate IEC 62304 and 510(k)
This bundle is for informational purposes only. Not legal or regulatory advice. Consult a qualified regulatory affairs professional for your specific situation.
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