SaMD IEC 62304 Software Lifecycle Toolkit: Development Plan to Verification
IEC 62304 Software Lifecycle Toolkit — software development plan, SRS template, architecture design, unit verification protocol, problem resolution procedure, and safety classification worksheet.
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Frequently Asked Questions
Which software safety class applies to my device?
Class A: no injury possible. Class B: non-serious injury possible. Class C: death or serious injury possible. The classification worksheet walks through the POSSIBLE HARM analysis with worked examples.
What is SOUP and why does it matter?
SOUP is pre-existing software incorporated without adequate development records. IEC 62304 requires documentation of SOUP version, published anomaly lists, and functional requirements. Most software uses open-source SOUP.
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.
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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.