MDR & Vigilance Reporting Toolkit: FDA 21 CFR Part 803 + EU MDR Articles 87-89
MDR and Vigilance Reporting Toolkit — FDA reportability decision framework, MedWatch 3500A template, EU MDR serious incident checklist, trend reporting template, FSCA/FSN package, and annual summary report.
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FDA Inspection Readiness Checklist
27-point checklist based on real 483 observations
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Implementation Quick-Start Guide
Step-by-step instructions to deploy templates in your QMS
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Frequently Asked Questions
What is the FDA MDR reporting timeline?
30 days for deaths and serious injuries, 5 days for events requiring immediate remedial action to prevent unreasonable risk of substantial harm.
When is EU MDR trend reporting required?
When a statistically significant increase in non-serious incidents compared to the established baseline is detected. The threshold must be defined in your PMS plan.
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.
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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.