FREE YOURSELF FROM DOCUMENTS
Revolutionize Medical Device Development and Quality Management With Data-Driven Solutions.
PRODUCT MANAGEMENT REIMAGINED
What is Fission™?
QUALITY AND COMPLIANCE
REGULATORY
DESIGN CONTROL
Fission™ is an all-in-one platform for medical device companies that is intuitive, ready to use, connects your product data, and includes the expertise needed to get your medical device to market and keep it compliant.
With Fission™, you get a comprehensive product development and quality management system that guides your product development process, keeping your product the center of focus – not compliance documents.
Our unique process seamlessly bridges engineering and compliance so your medical device remains on the cutting edge while also maintaining its compliant status.
A PLATFORM THAT CONNECTS IT ALL
Quality Management Systems
Build a foundation for success
Manage your quality processes with a data-driven approach that integrates seamlessly with your product and regulatory activities, keeping you audit-ready at all times.
Compliance to Regulations and Standards
Stay Ahead of Regulatory Challenges
Effortlessly align with FDA, ISO, and MDSAP standards through automated workflows that adapt to your global compliance needs.
Product Development
Turn Ideas Into Compliant Products
Simplify the development process with tools that guide you through design controls, risk management, and product lifecycle documentation—ensuring you’re always submission-ready.
BUILT WITH STARTUPS IN MIND, SCALABLE FOR ANY SIZE
Our platform is designed to support medical device companies at every stage of growth. Whether you’re navigating your first product launch or optimizing processes for a global operation, our data-driven approach simplifies FDA, ISO, and MDSAP compliance, no matter your company size.
For Startups
Lay the Foundation for Success
Effortlessly establish your first quality and regulatory processes while staying audit-ready. Our platform grows as you do, keeping things simple, yet scalable.
For Scaling Companies
simplify growth
Transition from startup to established business with tools designed to streamline compliance and integrate product, quality, and regulatory workflows as you expand.
For Enterprise-Level Teams
optimize and automate
Support global operations with advanced data-driven features that help automate quality management and maintain regulatory compliance efficiently at scale.
WHAT SETS FISSION APART: SMARTER, SIMPLER, SCALABLE
What makes us different
Our approach is data focused, not document focused. We connect your valuable device data ― the system provides guidance and recommendations to remain compliant when changes to your products are necessary.
Our approach informs you on the exact steps you need to take to get regulatory clearances, maintain compliance, and keep your products safe.
Automated submission documents ensure mistakes are avoided, deadlines are met, and your task list is shorter.
Built Around Data, Not Documents
Say goodbye to document overload. Fission connects your device’s data across all systems, ensuring accuracy and consistency without relying on cumbersome document management.
Affordable Flat-Fee Pricing Model
No surprises, no per-seat fees. Enjoy transparent, predictable pricing that delivers full access to our powerful platform—no matter how your team grows.
Seamless Scalability
Designed for startups but scalable for enterprises, Fission evolves with your business. Whether launching your first product or managing global operations, our platform adapts without adding complexity.
DATA THAT IS EASY AND READY TO USE
Our Solutions
User Needs and Product Requirements
Understand how users will interact with your products to better inform design.
Design Outputs
Maintain all of your design items in a Part 11 compliant database.
Quality Management System
Centralize and streamline quality processes with a system built to integrate design, regulatory, and product data—ensuring audit readiness and continuous compliance.
Regulatory submission document creation
System automatically creates submission documents based on current data.
Automated traceability between data points
Linked data ensures updates are automatically populated across your design eliminating errors.
Integrated risk management
Makes risk management a part of the design process to create safer products and reduce the risk of recalls.
