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We Transform Quality Systems. ISO 13485 Documentation. Processes. And Compliance. 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. Built specifically for innovative teams establishing and maintaining effective quality systems.
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Our AI-powered platform transforms how medical device developers approach quality management, bringing intelligence and simplicity to ISO 13485 documentation and processes.
Reduces quality documentation creation time by up to 70%. Generates comprehensive Quality Manual and standard operating procedures. Simplifies ISO 13485 compliance for early-stage teams. Join our waitlist to transform your quality management system.
IgniteQuality's AI assistant understands regulatory requirements and helps you create compliant documentation faster than ever before.
Smart TemplatesAI Content Generation
Compliance Checking Strong
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We designed IgniteQuality specifically for medical device teams that need to establish and maintain effective quality management systems.
Generate a comprehensive ISO 13485 Quality Manual tailored to your specific business needs and processes.
Create, store, and manage standard operating procedures with version control and approval workflows.
Access customizable templates for quality records, forms, and logs required for ISO 13485 compliance.
Map, document, and visualize your quality processes to ensure consistent implementation.
Track employee training requirements, completions, and competency assessments.
Plan, conduct, and document internal audits to verify QMS effectiveness and compliance.
IgniteQuality provides all the documentation needed for a complete medical device quality management system
The top-level document describing your QMS and quality policy.
Quality Policy Quality Objectives Organization Structure Process Interactions QMS Scope & ExclusionsStandard Operating Procedures (SOPs) that detail how processes are performed.
Document Control Training Internal Audits Corrective & Preventive Actions Design Control And 15+ more ISO 13485 proceduresDetailed step-by-step instructions for specific tasks.
How to perform specific tasks Department-specific instructions Detailed process steps Visual aids and diagramsTemplates and records that provide evidence of QMS activities.
Audit reports Training records CAPA forms Management review minutes Dozens of customizable templatesReduction in documentation creation time
Streamlined audit preparation
Decrease in documentation errors
Common questions about IgniteQuality's medical device quality management platform. Find answers to the most common questions about implementing our platform for medical device development.
Team Leader
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Team Leader
There are many variations of passages of Lorem Ipsum available,a but chiropractor like majority have a suffered alteration in some form, by injected humour,
Team Leader
There are many variations of passages of Lorem Ipsum available,a but chiropractor like majority have a suffered alteration in some form, by injected humour,
Team Leader
There are many variations of passages of Lorem Ipsum available,a but chiropractor like majority have a suffered alteration in some form, by injected humour,
Team Leader
There are many variations of passages of Lorem Ipsum available,a but chiropractor like majority have a suffered alteration in some form, by injected humour,
Team Leader
There are many variations of passages of Lorem Ipsum available,a but chiropractor like majority have a suffered alteration in some form, by injected humour,
Our platform is designed specifically for innovative teams developing medical devices across various categories, helping you maintain quality and compliance throughout your development process.
In-vitro and imaging diagnostic solutions
Connected health monitoring devices
Patient-critical monitoring systems
Treatment and therapeutic technologies
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There are many variations of passages of Lorem Ipsum available, but the majority
There are many variations of passages of Lorem Ipsum available, but the majority
There are many variations of passages of Lorem Ipsum available, but the majority
There are many variations of passages of Lorem Ipsum available, but the majority
There are many variations of passages of Lorem Ipsum available, but the majority
There are many variations of passages of Lorem Ipsum available, but the majority
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.
