Clinical Investigations & IDE Toolkit: FDA Part 812 + ISO 14155 Templates
Clinical Investigations and IDE Toolkit — IDE application guide, clinical investigation plan, IRB checklist, adverse event SOP, site monitoring plan, and final study report template.
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of real FDA 483 observations
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FDA Inspection Readiness Checklist
27-point checklist based on real 483 observations
Quarterly Regulatory Updates
Free updates when FDA guidance changes
Implementation Quick-Start Guide
Step-by-step instructions to deploy templates in your QMS
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Benefits
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This toolkit is designed for teams facing these challenges:
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Frequently Asked Questions
When is an IDE required?
An IDE is required for significant risk device studies involving human subjects. Non-significant risk devices require IRB approval but not an FDA IDE. The IDE application guide includes the NSR/SR determination framework.
Can these templates be used for EU clinical investigations?
Yes. The Clinical Investigation Plan template is aligned with both FDA 21 CFR Part 812 and ISO 14155:2020, which is the standard used for EU MDR clinical investigations.
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.
Ready to Get Audit-Ready?
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.