About Us
There is a great unmet need in the medical device industry when it comes to product development and regulatory compliance.
- Solutions are siloed between development and regulatory teams
- eQMS software generally provides digitized templates of documents without guidance or direction on how to complete
- Multiple consultants are necessary but vary in ability, knowledge, and skill, and are costly.
This has left significant gaps in processes and frustration for small med device companies who want to focus on their product. Because if this, we’ve developed Fission to provide a fully outsourced Development and Compliance Solution.
At Fission®, we didn’t just aim to fill the gaps—we reimagined the entire process.
- Fission® combines a powerful data-centric platform with an experienced team that understands the unique challenges of medical device companies.
- Fission® puts your product—not your documents—at the center of development and compliance activities.
- Our data-first platform obsoletes cumbersome documentation, linking individual data points to instantly identify the impact of changes in design, verification/validation testing, processes, or regulations.
- No more document control – Submission ready documents are automatically generated when you need them.
Our mission powers us
At Fission®, we empower medical device companies of all sizes to innovate and deliver safe, effective technology to market faster. By putting your product—not documents—at the center of compliance and development, we simplify design controls, streamline processes, and free teams to focus on advancing their products’ impact.
Our Approach
Fission® makes valuable information easily accessible ― not buried in documents ― and automatically identifies impacts throughout the system that are triggered by a single change.
Our Mission
At Fission®, we empower medical device companies of all sizes to innovate and deliver safe, effective technology to market faster. By putting data—not documents—at the center of product development and quality management, we simplify compliance, streamline processes, and free teams to focus on advancing their products and impact.
Our Beliefs
- Data—not documents—drives better decisions.
- Your product should lead all development and compliance activities.
- Accessible and streamlined data improves efficiency.
- A well-designed system lets you focus on your product, not the process.
- Automation and AI should reduce your workload, not add to it.
- Access to expert support is non-negotiable.
Why Fission Is the Right Partner for Your Medical Device Journey
Your product is always our priority.
Fission ensures every step of your product journey is designed around your success.
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.
Transparent, affordable pricing.
No surprises, no per-seat fees. Enjoy flat-fee pricing that gives you 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.
Quality and compliance are seamlessly integrated.
Transform compliance from a burden into a value-driven, streamlined workflow.
Expertise across all areas of medical device development.
Our diverse team brings specialized knowledge to support your journey from design to commercialization.
Standardized workflows simplify processes.
Take the guesswork out of device development with proven, efficient workflows.
End-to-end support for peace of mind.
Fission’s dedicated support ensures continuous compliance and clarity at every stage—without the need for external consultants.
