Complete Compliance Suite: Build Your Entire QMS in 30 Days — Not 12 Months
Every RegWatchDaily toolkit in one package. 98 toolkits, 100+ templates, complete QMS coverage. Save over $2,000 vs buying individually.
Save $2250 vs buying separately
A consultant would charge $7,976+ for this documentation. Get it instantly for $997.
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.
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's included in the Complete Compliance Suite?
All 15 individual toolkits: QMS Documentation, Design Controls, CAPA, Risk Management, Supplier Controls, 510(k) Submission, SaMD/Cybersecurity, Clinical Evaluation (CER), Post-Market Surveillance, QMSR Transition, Internal Audit, Complaint Handling, Process Validation, Labeling/IFU, and MDSAP Audit. Over 100 editable documents total.
What file formats are included?
All documents are in editable Microsoft Word (.docx) and Excel (.xlsx) formats as applicable. No special software required — everything works in standard Microsoft Office.
Who is this for?
Medical device companies at any stage who want complete QMS documentation coverage without the $200,000+ consultant price tag. Ideal for Series A/B funded startups, lean QA/RA teams at established manufacturers, and consultants supporting multiple clients.
Does this cover FDA, EU MDR, and ISO 13485?
Yes. Templates are aligned with FDA 21 CFR Part 820/QMSR, ISO 13485:2016, EU MDR 2017/745, IEC 62304 (software), ISO 14971:2019 (risk), and MDSAP (five-country audit program).
How long does full implementation take?
With a dedicated QA/RA resource: core QMS operational in 4-6 weeks, full suite implemented in 3-6 months. The Quick Start Guide included with the suite provides a phased implementation roadmap.
How does this compare to hiring a QMS consulting firm?
A full QMS build from a consulting firm runs $50,000-200,000+. This suite gives you the same documentation architecture — your team implements it, with support at support@regwatchdaily.com when questions arise.
Are there payment plan options?
Yes. The suite is available as a one-time payment or as 3 monthly payments of $349. Both options include the complete package and all future updates.
Will I get updates as regulations change?
Yes — free lifetime updates by email for all 98 toolkits. QMSR (Feb 2027), EU MDR amendments, and ISO standard revisions are all covered.
What's your refund policy?
7-day Audit-Ready Guarantee. Full refund within 7 days — email support@regwatchdaily.com. Given the scope of the suite, we strongly recommend downloading all files and reviewing them before day 7.
Can I use this for an FDA inspection or Notified Body audit?
Yes. The suite is designed so every procedure and record is audit-ready from day one. Many customers report passing FDA inspections and ISO 13485 certification audits using these templates as their QMS foundation.
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.