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.
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Frequently Asked Questions
What file formats are included?
All 9 templates are in Microsoft Word (.docx) format. The SOUP List is an Excel workbook with risk scoring fields. The SBOM template follows CycloneDX JSON structure.
Which regulations and standards does this cover?
IEC 62304:2006+AMD1:2015 (software lifecycle), FDA's 2023 Cybersecurity Guidance, FDA's 2019 SaMD guidance, ISO 14971:2019 (software risk), and EU MDR software rules under Article 2(1).
How do I determine my IEC 62304 safety class?
The SaMD Classification Worksheet walks you through both FDA's SaMD framework (significance × state of healthcare) and IEC 62304's Class A/B/C determination. Class drives your documentation depth.
Who is this for?
Software development teams at medical device companies, standalone SaMD startups, and RA professionals supporting software submissions. Valuable whether you're building a Class A utility or a Class C AI-driven diagnostic.
Does this cover AI/ML medical devices?
The Cybersecurity Risk Assessment and SaMD Classification Worksheet include FDA AI/ML guidance considerations (Predetermined Change Control Plans, etc.). This is a rapidly evolving area — we include notes on checking FDA's latest AI/ML guidance documents.
What's a SOUP and why does it matter?
SOUP = Software of Unknown Provenance — third-party libraries and components your software depends on. IEC 62304 requires you to document, risk-assess, and verify every SOUP item. The SOUP List template makes this systematic.
How long does IEC 62304 documentation take?
For a Class B device with a small team: 4-8 weeks to create baseline documentation. Class C or complex architectures: 2-4 months. The Software Development Plan template structures all required activities.
Will I get updates when FDA cybersecurity guidance changes?
Yes — free updates by email. FDA's cybersecurity space is active; we revise templates when new guidance is finalized.
What's your refund policy?
7-day Audit-Ready Guarantee. Full refund within 7 days — email support@regwatchdaily.com.
How does this integrate with design controls and risk management?
The Software Development Plan references your Design & Development Plan. The SOUP Risk Assessment links to your ISO 14971 risk file. All integration points are explicitly marked in the templates.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your company's branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, you'll receive an email with download links within 2-3 minutes. Check your spam folder if you don't see it.
Can I use these for multiple projects or clients?
Yes. Your purchase includes a company-wide license. Use the templates across all your projects and devices within your organization.
Do these templates get updated when regulations change?
Yes. You'll receive free updates via email whenever we update templates for new guidance or regulatory changes.
What if I need help customizing the templates?
Email us at support@regwatchdaily.com. We typically respond within 24 hours with guidance on customization.
Is there a money-back guarantee?
Yes — the Audit-Ready Guarantee. If you're not satisfied within 7 days, email us for a full refund. No questions asked.
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7-Day Iron-Clad Guarantee
Download everything. Review every template. If it doesn't save you at least 40 hours of documentation work, email us for a full refund. No questions. No hassle.
Every week without proper documentation is another week of audit exposure.