Medical Device Clinical Ethics & IRB Toolkit: Human Subjects Research Templates
Medical Device Ethics and IRB Toolkit — IRB application template, informed consent form, protocol amendment procedure, adverse event reporting to IRB, continuing review, and IRB closure request.
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What's Inside
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of real FDA 483 observations
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Plus You'll Get These Bonuses Free
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
Total Bonus Value: $173+ — Yours FREE with purchase
Benefits
What QA/RA Professionals Say
Join 500+ medical device companies using RegWatchDaily templates
“These templates saved us months of work. We passed our FDA inspection on the first try.”
“Finally, templates that actually reflect how FDA inspectors think. Worth every penny.”
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Is This For You?
This toolkit is designed for teams facing these challenges:
Who This Is For
The Audit-Ready Guarantee
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Frequently Asked Questions
Is IRB approval required for all medical device clinical studies?
IRB approval is required for all research involving human subjects conducted under an FDA-regulated investigation. This includes IDE studies and any clinical investigations used to support FDA submissions.
What format are the documents?
All documents are editable Word 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.
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.