I g n i t e Q u a l i t y

Loading

Contact Info

Get A Quote
Get Started
shape
shape
shape
shape
shape
News!Find Your Solution icon

Quality Management for Innovators.

We create Quality Management Systems. A general quality management system compliant to ISO 9001 and a specialist Medical Device Quality Management System in accordance with ISO 13485. Our modules are developed by leading experts in the medical device design, manufacture and service fields.
Our AI-powered platform streamlines quality management, drastically reducing the time and resources spent on documentation. This allows your team to focus on innovating and delivering while still maintaining structured quality processes and producing essential records for you technical files.

Get Started Now Learn More
thumbShape
thumbShape
thumb
How It Work icon

A Effective and Efficient Quality Management Systems Tailored for your Company

shape
STEP - 01
Define Your Quality System
Tell us about your company and we'll help you build a quality management system that meets ISO 9001 or ISO 13485 requirements.
STEP - 02
Generate Documentation
Our AI creates your Quality Manual, SOPs, and forms tailored to your specific processes and company structure. We can provide training presentations to assist with the implementation of procedures.
STEP - 03
Implement & Maintain
Seamlessly implement your quality system and easily maintain it as your company evolves and grows.

See It in Action

Get Started Now
shape
shape
shape
shape
thumb
thumb
About Our Platform icon

Quality Documentation & ISO Compliance Reimagined

Our AI-powered platform transforms how innovators and manufacturers approach quality management, bringing intelligence and simplicity to ISO 9001 and ISO 13485 documentation and processes.

  • icon Reduces quality documentation creation time by up to 80%.
  • icon Generates comprehensive Quality Manual and standard operating procedures.
  • icon Simplifies ISO 9001 and ISO 13485 compliance for early-stage teams.
  • icon Join our waitlist to transform your quality management system.
Discover More
AI-Powered Document Generation icon

Create Regulatory Documents in Minutes, Not Weeks

IgniteQuality's AI assistant understands regulatory requirements and helps you create compliant documentation faster than ever before.

  • icon Smart Templates
  • iconAI Content Generation
  • icon Compliance Checking
  • icon Secure Environment
Get Started Now
thumb
shape
Why IgniteQualityicon

Built to assist Quality Managers and be easily used by Development and Operational teams

We designed IgniteQuality for teams that need to establish and maintain effective quality management systems.

icon

Quality Manual Builder

Generate a comprehensive ISO 9001 or ISO 13485 Quality Manual tailored to your specific business needs and processes.

icon

Internal Management and Audit Tools

Plan, conduct, document and follow up internal Quality Management Reviews, audits and customer Satisfaction surveys to verify QMS effectiveness and compliance.

icon

Forms & Records

Access customizable templates for quality records, forms, and logs required for ISO 9001 and ISO 13485 compliance.

thumb
shape
icon

Process Documentation

Map, document, and visualize your quality processes to ensure consistent implementation.

icon

Staff On-Boarding And Training Management

Manage Job Descriptions, Employee Contracts, Qualifications and References. Track employee training requirements, completions, and competency assessments.

icon

SOP Management

Quickly create, store, and manage standard operating procedures with version control and approval workflows.

Our modular design allows you to add the relevant modules when you need them

Is IgniteQuality Validated?

Because IgniteQuality software platform is a critical software used within the quality management system, IgniteQuality provides validation information to support all customers, in demonstrating compliance during an audit.

JHQ< HUJ

Compared to manual documentation

80 %

Reduction in documentation creation time

85 %

Streamlined audit preparation

65 %

Decrease in documentation errors

FAQs icon

Frequently Asked Questions

Common questions about IgniteQuality's quality management system platform. Find answers to the most common questions about implementing our platform for medical device development.

IgniteQuality has been developed by leading experts from the Quality field including the medical device industry and our ISO 13485 module is applicable to any medical device and diagnostics company. Alternatively our ISO 9001 module can be used by any company that is required to have a quality management system for certified quality control, including suppliers and service providers from the following industries:
  • Health technology and life sciences
  • Industrial biotechnology and chemical industry
  • Clean technology
  • Aerospace and defense
  • Food and agricultural technology
  • Manufacturing industries
Yes, IgniteQuality is built from the ground up to support ISO 13485 compliance with document control, version tracking, and the full suite of quality system documentation required by the standard. It also supports 21 CFR Part 11 compliance with electronic signatures, audit trails, and secure access controls.
Our AI-powered platform asks you targeted questions about your company and processes, then generates a complete, customized quality manual that meets ISO 9001 and ISO 13485 requirements. The entire process takes a fraction of the time compared to traditional methods. Our platform adapts to various regulatory approaches, whether you're pursuing 510(k), De Novo, PMA, EU MDR compliance, or other international standards.
Absolutely. IgniteQuality is designed to scale with your organization, from startup to established manufacturer. Our platform adapts as your quality system matures and your product portfolio expands.
We're currently in development and will be launching to select early access partners soon. Join our waitlist to be notified when we're ready.
A quality management system (QMS) is a structured framework of policies, processes, and procedures that an organization implements to ensure their products and services consistently meet customer and regulatory requirements. It documents responsibilities, coordinates activities, and enhances efficiency while reducing waste. Its ultimate goal is to improve customer satisfaction and drive continuous improvement.
A QMS is necessary for any organization that wants to deliver high-quality products or services consistently, especially in regulated industries. Medical device manufacturers, for example, must have a QMS to meet ISO 9001 and ISO 13485 before marketing in the US, Canada, or Europe. Ideally, it should be implemented during the product design phase.
Implementing a QMS offers many benefits:
  • Improved Customer Satisfaction: Ensures consistent product/service quality.
  • Enhanced Efficiency and Reduced Waste: Streamlines operations and reduces errors.
  • Regulatory Compliance: Helps meet industry standards and avoid penalties.
  • Better Decision-Making: Enables data-driven processes.
  • Continuous Improvement: Encourages ongoing evaluation and refinement.
  • Increased Employee Engagement: Clarifies roles and boosts ownership.
Yes, a QMS offers a significant cost-benefit. Though it involves initial costs (training, documentation), the long-term gains—improved efficiency, fewer errors, better compliance, greater customer satisfaction, better employee engagement and retention—far outweigh these. The "cost of quality" framework shows that investing in prevention reduces the cost of failures, leading to profitability
shape
shape
shape
shape
Quality System Visualization icon

Join our contact list to transform your quality management system

Our AI-powered platform streamlines quality management for medical device developers, drastically reducing the time and resources spent on documentation. This allows your team to focus on innovating and delivering while still maintaining structured quality processes.

Get Started Now
thumb