Stop starting from scratch
Practical, editable compliance templates for medical device, software, and regulated teams. Built by practitioners, not consultants.
Your Compliance Kit
Audit-ready documentation
Quality Management System
157 templates
Software Lifecycle
35 templates
Information Security
98 templates
+ 4 more template sets
500+
Teams worldwide
1,500+
Kits downloaded
4.8/5
Average rating
Why teams choose RegFast
Practitioner-written
Templates built by people who have been through certification audits.
Fully editable
.docx and .md formats. No lock-in, no proprietary software.
Instant access
Download immediately. No sales calls, no demo scheduling.
Team license
Share across your entire organization. One purchase, unlimited users.
Always current
Regular updates when standards change.
Expert support
Customization and implementation services available.
Compliance template sets
Professional, audit-ready documentation — editable and built for real-world implementation.
ISO 13485 QMS
Complete QMS documentation for medical device manufacturers. Aligned with EU MDR and FDA QSR.
ISO 14971 Risk Management
Structured risk management documentation including FMEA and hazard traceability.
IEC 62366-1 Usability
Usability engineering documentation aligned with FDA human factors guidance.
How it works
From download to certification-ready documentation in three simple steps.
Download free samples
Get real, production-ready templates for any standard. No credit card, no signup.
Choose your kit
Select Free, Mandatory, or Full Compliance Kit based on your needs.
Edit and certify
Adapt templates to your organization. Audit-ready from day one.
Start with the free starter kit
Everything you need to start your compliance documentation — no credit card required.
No spam. Instant download.
Need hands-on help?
When you need more than templates, we help execute.
Template Customization
We adapt templates to your company structure and terminology.
Documentation Support
Structure and compile your documentation into audit-ready packages.
Full Implementation
We build your documentation system from start to finish.
Start with structure, not a blank page
Practical templates and starter systems for regulated documentation. Clear foundations you can build on, with hands-on help available when you need it.
Need hands-on help? Get in touch