Build Your ISO 13485-Ready QMS with AI-Powered Documentation
Create a complete Quality Management System with compliant SOPs, policies, and documentation for medical devices in days, not months.
Limited Time Offer: Get 20% off any annual plan with code LAUNCH20 — Offer ends in 7 days!
75%*
Less Time Required
90%
Reduced Documentation Errors
$20K+
Average Consultant Savings
* Compared to manual document preparation methods
The Manual QMS Documentation Nightmare
Medical device companies waste thousands of hours and dollars on outdated documentation processes.
Without DocuOrbit
- Weeks spent drafting hundreds of documents from scratch
- $15,000-$30,000+ for consultants and manual documentation
- Multiple stakeholders struggling with version control
- Compliance gaps and audit failures due to human error
With DocuOrbit
- Build an industrial-level Quality Management System with minimal resources
- Create complete QMS documentation for ISO 13485 certification
- Save up to 80% on compliance-related costs
- AI-powered document lifecycle validation and updates with AI agent support for surveillance audits
Key Features
Everything you need to achieve ISO 13485 certification, faster and with fewer resources.
AI Document Generation
Generate compliant SOPs, policies, and work instructions through an intuitive question-answer flow.
Compliance Validation
Automated checks ensure every document meets ISO 13485 requirements and industry best practices.
Team Collaboration
Role-based access, commenting, and approval workflows streamline the documentation process.
Document Templates
Access 100+ pre-built templates covering all ISO 13485 documentation requirements.
Version Control
Track changes, maintain revision histories, and ensure you're always audit-ready.
Cost-Effective
Eliminate expensive consultants and complex software with our affordable subscription model.
What You Get with DocuOrbit
A comprehensive set of ISO 13485-compliant documentation tailored to your organization
Core QMS Documentation
- Quality Manual
Comprehensive overview of your QMS structure, including scope, exclusions, and process interactions
- Quality Policy
Clear statement of your organization's commitment to quality and continuous improvement
- Quality Objectives
Measurable goals aligned with your quality policy and business objectives
- Organizational Structure
Defined roles, responsibilities, and authorities within your QMS
- Document Control Procedures
Processes for creating, reviewing, approving, and managing QMS documentation
- Record Control Procedures
Systems for maintaining, storing, and retrieving quality records
Process Documentation
- Management Review Procedures
Processes for periodic evaluation of QMS effectiveness and opportunities for improvement
- Internal Audit Procedures
Methodologies for planning and conducting internal quality audits
- Corrective and Preventive Action (CAPA) Procedures
Systematic approaches to addressing nonconformities and preventing recurrence
- Design and Development Procedures
Processes for planning, controlling, and validating product design activities
- Purchasing and Supplier Management Procedures
Systems for evaluating, selecting, and monitoring suppliers
- Production and Service Provision Procedures
Controls for ensuring consistent product quality during manufacturing
Risk Management Documentation
- Risk Management Plan
Framework for identifying, analyzing, and controlling risks throughout product lifecycle
- Risk Assessment Procedures
Methodologies for evaluating and documenting product and process risks
- Risk Control Measures
Strategies for mitigating identified risks to acceptable levels
- Risk Management Reports
Documentation of risk management activities and results
Measurement & Improvement
- Customer Feedback Procedures
Systems for collecting and analyzing customer satisfaction data
- Complaint Handling Procedures
Processes for receiving, documenting, and addressing customer complaints
- Nonconforming Product Procedures
Controls for identifying, segregating, and dispositioning nonconforming products
- Monitoring and Measurement Procedures
Methods for tracking QMS performance and product characteristics
Additional Resources & Templates
Beyond the core documentation, DocuOrbit provides a comprehensive library of supporting templates and forms:
How It Works
Four simple steps to build a complete ISO 13485-ready Quality Management System
Upload Your Documents
Import your existing quality system documentation, organizational processes, and company information to create a knowledge foundation.
AI-Guided Questions
Our AI assistant analyzes your documents and guides you through targeted questions about your organization's processes, resources, and quality objectives.
Context-Aware Generation
The AI generates QMS documentation that incorporates your organizational context, maintaining consistency across all quality management processes.
Review & Finalize
Collaborate with your team to review, refine, and approve all documents, then export them for certification submission.
More Than Just Document Generation
Our AI agent does more than just generate documents. Working step by step with the employee responsible for quality, it helps build a real, functioning Quality Management System and creates documentation that reflects the system as it actually operates.
Who Benefits from DocuOrbit?
Our platform is designed for everyone involved in the medical device compliance process
MedTech Startups
For companies that need to build QMS and get ISO 13485 certification without hiring expensive consultants or diverting engineering resources.
QA & Regulatory Professionals
Streamline documentation work and focus on strategic compliance tasks instead of paperwork.
ISO Consultants
Serve more clients efficiently with our AI tools, while providing greater value and expertise.
Technical Founders
Focus on product development while ensuring your compliance foundation is solid from day one.
COOs & Operations Leaders
Implement quality management systems without disrupting existing operations or overburdening staff.
Small/Medium Device Manufacturers
Maintain ISO 13485 compliance without the overhead of large quality departments or expensive QMS software.
Simple, Transparent Pricing
Plans designed to fit your organization's size and needs
Startup
For early-stage companies with under 10 employees
- Build QMS system with AI
- Create documents set for ISO 13485
- Basic version control
- Email support
30-day money-back guarantee
Growth
For scaling companies with 10-50 employees
- Everything from Startup plan
- ISO 14971, ISO 10993-1
- IEC 62304
- Advanced version control
- Priority support
30-day money-back guarantee
Enterprise
For established medical device companies
- Everything from Growth plan
- IEC 60601, IEC 62366-1, IEC 81001-5-1…
- RMF documents set for each product
- Dedicated Support Manager
Custom implementation available
Have questions about pricing or which plan is right for you?
All plans include:
Frequently Asked Questions
How does the AI generate ISO 13485 compliant documentation?
Our AI has been trained on thousands of ISO 13485 compliant documents and industry best practices. It understands the standard's requirements for quality management systems and generates documentation tailored to your organization's specific context, processes, and objectives.
What specific documents will I receive?
DocuOrbit provides a comprehensive set of ISO 13485 documentation including your Quality Manual, Quality Policy, all required procedures (document control, record control, internal audit, CAPA, etc.), work instructions, forms, and templates. See our "What You Get" section for a detailed breakdown of all deliverables.
Can DocuOrbit help with FDA or MDR compliance too?
While our initial focus is on ISO 13485, our platform is designed to be expandable. We're already working on FDA 21 CFR Part 820 and EU MDR compliance modules that will be available in future updates.
Does DocuOrbit guarantee ISO 13485 certification?
DocuOrbit helps you create a Quality Management System with documentation that meets ISO 13485 requirements, but certification itself depends on your organization's implementation of these processes and the assessment by a certification body. Our platform provides the foundation for a successful certification process, but we don't guarantee certification outcomes.
Is my data secure and confidential?
Absolutely. We maintain the highest security standards with end-to-end encryption, regular security audits, and strict access controls. Your proprietary information never leaves our secure environment and is never used to train our AI.
Can I customize the generated documents?
Yes, all generated documents can be fully customized within our platform. You can edit content, add company-specific information, and make any necessary adjustments before finalizing your documentation.
How long does it take to get started?
You can sign up and start using DocuOrbit immediately. Most companies can complete the questionnaire in 2-3 hours, after which our AI generates all required documentation within minutes. The total time from sign-up to having a reviewable set of documents is typically less than one day.
Do you offer consultancy services for implementation?
Yes, while DocuOrbit is designed to be a self-service platform that eliminates the need for expensive consultants, we understand that some organizations may need additional guidance. We partner with certified ISO 13485 consultants who can provide expert assistance at $175/hour if you need specialized help with implementation, audits, or complex compliance questions. Our Enterprise plan includes access to these implementation specialists, and all customers can book consultation sessions through our platform as needed.
See DocuOrbit in Action
Schedule a personalized demo to see how our AI-powered platform can transform your ISO 13485 documentation process
What to Expect
- 1
30-Minute Personalized Demo
See the platform in action with a walkthrough tailored to your needs
- 2
Q&A Session
Get answers to your specific questions from our product experts
- 3
Implementation Discussion
Learn how DocuOrbit can be integrated into your existing workflow
No obligation or pressure to purchase
Have questions before scheduling?
Our team is ready to help you understand how DocuOrbit can meet your specific needs.
Contact Us DirectlyReady to Transform Your ISO 13485 Documentation Process?
Reach out to learn how DocuOrbit can help your team build a complete, audit-ready Quality Management System.