QMS Essentials Bundle: 3 Core Toolkits for FDA Compliance
Get QMS Foundations + Design Controls + CAPA toolkits at a bundled price. Perfect for teams building their first FDA-compliant QMS.
Save $2750 vs buying separately
What's Included
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's included in the bundle?
QMS Foundations Pack (9 documents: document control, training, management review), Design Controls Toolkit (9 documents: DHF, inputs, outputs, V&V, transfer), and CAPA Toolkit (8 documents: RCA, action plans, effectiveness verification). 26 documents total.
How much do I save?
You save $191 compared to buying the three toolkits separately ($197 + $247 + $247 = $691). Bundle price is $497.
What file formats are included?
All 26 documents are in editable Microsoft Word (.docx) and Excel (.xlsx) formats as applicable. Immediately customizable to your company.
Why these three toolkits together?
These three address the top 3 FDA 483 observation categories (design controls #1, CAPA #2, QMS documentation #3). Together they cover 80% of the most common regulatory gaps for Class II device manufacturers.
Who is this bundle for?
Startups building their first QMS, established companies with a 483 in one or more of these areas, and QA managers who need to get a compliant system in place fast with limited budget.
Does this cover FDA only, or also EU MDR and ISO 13485?
All three toolkits are aligned with FDA 21 CFR Part 820, ISO 13485:2016, and QMSR. Many documents are also structured to support EU MDR technical documentation requirements.
How long to implement all three toolkits?
With dedicated effort, 4-6 weeks to adopt procedures, set up records infrastructure, and document your first management review and CAPA. Design controls implementation runs concurrent with active development projects.
Will I receive updates to all three toolkits?
Yes — free updates by email for all 26 documents whenever we revise for regulatory changes. One purchase covers all future updates.
What's your refund policy?
7-day Audit-Ready Guarantee. Full refund within 7 days — email support@regwatchdaily.com.
What should I add next after this bundle?
Risk Management Toolkit (ISO 14971) and Supplier Controls Toolkit are the logical next additions. For submission-readiness, add the 510(k) Submission Toolkit or complete the journey with the Complete Compliance Suite.
What file format are the templates in?
All templates are provided in editable Microsoft Word (.docx) format. You can customize them to match your companyx27s branding and specific requirements.
How quickly will I receive the files?
Instantly. After purchase, youx27ll receive an email with download links within 2-3 minutes. Check your spam folder if you donx27t 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. Youx27ll 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 youx27re not satisfied within 7 days, email us for a full refund. No questions asked.