Save time on regulatory documentation
Focus on your product, not the paperwork. RegFast gives you practical, editable compliance templates built for medical device, software, and regulated teams — with optional hands-on support when you need it.
Ready-to-use templates for ISO 13485, IEC 62304, ISO 27001, ISO 42001, ISO 14971, IEC 62366-1, and EU AI Act compliance.
Ready-to-use templates for ISO 13485, IEC 62304, ISO 27001, ISO 42001, ISO 14971, and EU AI Act compliance
Quality System Essentials
Core procedures & forms
Product Documentation Kit
Technical file ready
Risk & Safety Documentation
Structured & ready
Three ways to get compliant, fast
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Download in .docx and .md formats. Adapt to your organization, product, and regulatory context. Audit-ready from day one.
Built for regulated teams
Quality Managers
Build and maintain your QMS without starting from scratch. Templates map directly to ISO 13485, ISO 9001, and ISO 27001 clauses.
Regulatory Consultants
Equip yourself with structured, repeatable documentation you can adapt across multiple clients and device classifications.
SaMD Startups
Move fast without breaking compliance. Software lifecycle docs aligned with IEC 62304 and EU AI Act requirements.
Medtech Engineers
Focus on product development while we handle the paperwork. Risk management and usability engineering templates included.
Compliance template sets
Ready-to-use templates for the standards you need. Professional, audit-ready documentation — editable and built for real-world implementation.
ISO 13485 QMS
Medical Device Quality Management System
Complete QMS documentation for medical device manufacturers. Covers quality manual, document control, design and development, purchasing, CAPA, management review, and post-market surveillance. Aligned with EU MDR and FDA QSR 21 CFR 820 requirements.
Best for: Medical device companies seeking ISO 13485 certification or maintaining an existing QMS.
IEC 62304 Software Lifecycle
Medical Device Software Documentation
Software lifecycle documentation for SaMD and SiMD products. Includes software development plan, requirements specification, architecture design, unit/integration/system test plans, software maintenance, and software configuration management. Covers all three safety classes (A, B, C).
Best for: Medtech software teams building regulated medical device software.
ISO 27001 ISMS
Information Security Management System
Full ISMS documentation covering context, leadership, planning, support, operation, performance evaluation, and improvement. Includes all Annex A controls (A.5–A.18) with statement of applicability. Ready for certification audits.
Best for: Organizations implementing or maintaining an ISO 27001-certified ISMS.
ISO 42001 AIMS
AI Management System
The first international standard for AI governance. Templates cover AI policy, risk assessment, impact evaluation, AI system inventory, and continual improvement processes. Designed for organizations developing or deploying AI systems.
Best for: AI companies and AI-enabled medical devices needing structured governance.
ISO 14971 Risk Management
Medical Device Risk Management
Structured risk management documentation covering hazard identification, risk estimation, risk evaluation, risk control, residual risk evaluation, and risk management review. Includes FMEA and hazard traceability matrix templates.
Best for: Risk managers and design engineers documenting risk throughout the product lifecycle.
IEC 62366-1 Usability Engineering
Medical Device Usability
Usability engineering documentation for medical device user interface design. Covers use specification, usability risk analysis, formative and summative evaluation, and usability validation. Aligned with FDA human factors guidance.
Best for: UX researchers and human factors engineers preparing regulatory submissions.
EU AI Act Compliance
AI Governance & Regulatory Compliance
Documentation for compliance with the EU AI Act across all risk categories. Includes risk management system, technical documentation, conformity assessment, transparency obligations, and human oversight. Covers high-risk AI system requirements.
Best for: AI system providers and deployers preparing for EU AI Act enforcement.
Why RegFast?
Not checkbox compliance
Our templates are written by practitioners, not consultants. They reflect real-world documentation that auditors actually want to see.
Editable formats
Delivered as .docx and .md files. No proprietary software, no locked-down PDFs. Adapt every template to your organization.
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Team-licensed
Share across your team. Every purchase includes a license for use within your organization — not per-user pricing.
Regularly updated
Standards evolve, and so do our templates. When regulations change, your documentation stays current.
Hands-on support available
Need more than templates? We offer customization, documentation packaging, and full implementation services.
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Everything you need to start your compliance documentation without the overwhelm — no credit card required.
- Documentation checklist
- Regulatory pathway decision tree
- Essential document list
- Quick-start implementation guide
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Templates plus hands-on support
When you need more than templates, we help execute.
Template Customization
We adapt templates to your company structure, product type, and terminology. Get a tailored documentation set without the cost of full consultancy.
Documentation Support
Structure and compile your technical documentation into coherent, audit-ready packages. We review, organize, and fill gaps in your existing documentation.
Full Implementation
We build your documentation system from start to finish — from gap analysis through template population to final documentation package ready for certification audit.
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.
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