Dual Compliance Kit: FDA + EU MDR Harmonized Documentation
Harmonized procedures that satisfy both FDA and EU MDR requirements. Single documentation system for US and European market access.
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A consultant would charge $1,576+ for this documentation. Get it instantly for $197.
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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.
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What's Inside
ready to customize
of real FDA 483 observations
(vs. 4–6 weeks with a consultant)
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.”
“We've used consultant templates before. These are better — more practical, less fluff.”
Is This For You?
This toolkit is designed for teams facing these challenges:
Who This Is For
The Audit-Ready Guarantee
Try the toolkit for 7 full days. If you don't feel more confident about your next FDA inspection, email us and we'll refund every penny — no questions asked. You keep the templates.
Your investment is 100% protected.
Frequently Asked Questions
What file formats are included?
All 6 templates are delivered as editable Microsoft Word (.docx) files, ready for immediate customization.
Do I still need a Notified Body for EU?
Yes, for Class IIa and above devices. This toolkit prepares your documentation for NB review — it doesn't replace the NB certification process itself.
Who is this for?
US companies seeking EU MDR certification, EU companies entering the FDA market, and any manufacturer maintaining dual regulatory filings. Works for Class I-III devices.
Does this include the full Technical File?
It includes the structure and key templates for EU MDR Technical Documentation (Annex II). Clinical evaluation, risk management, and design documents are covered in their respective toolkits.
How does this handle FDA vs EU MDR differences?
The Harmonized Gap Analysis Matrix maps every requirement side-by-side, highlighting where they align (most of QMS) and where they diverge (clinical evidence requirements, UDI specifics, PMCF obligations).
How long does dual-compliance implementation take?
Establishing harmonized documentation typically takes 4-8 weeks for a company with an existing QMS. Net-new QMS implementation with dual compliance takes 3-6 months.
Will I get updates when EU MDR requirements change?
Yes. Free updates by email when we revise for EU MDR amendments, MDCG guidance updates, or FDA regulatory changes.
What's your refund policy?
7-day Audit-Ready Guarantee — full refund if not satisfied, no questions asked. Email support@regwatchdaily.com.
How does this compare to a regulatory consultant?
Regulatory consultants charge $200-400/hour for dual-compliance gap analyses. This toolkit gives you the same framework for a fraction of the cost, with your team doing the work.
Can we use this to prepare for a Notified Body audit?
Yes. The Technical Documentation Template and Declaration of Conformity are structured to match NB expectations. Pair with the Clinical Evaluation and Risk Management toolkits for complete NB readiness.
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.