Built on Data. Not Documents.
A modern platform for medical device development.
Fission replaces disconnected templates and word docs with structured, traceable data: giving you real-time visibility, built-in quality, and automated documentation.
Why Traditional Systems Hold You Back
Most eQMS tools just digitize paper, filling your workflow with templates, disconnected Word files, and manual trace matrices.
Fission flips the model:
- Data first architecture gives you love traceability across requirements, risks, and tests
- Documents are generated on demand from real-time data
- No more formatting. Nom more emailed redlines. No more duplicated effort. No more guesswork.
If you’re still managing folders of documents, you’re moving slower than you need to.
For Founders & Engineers
Tired of managing Word docs, templates, and disconnected spreadsheets?
For Quality Managers
Quality is your job, but it shouldn’t slow innovation.
For Everyone
Most tools assume you’re a 200-person company. Fission doesn’t.
From QMS to Design Lifecycle Management
Fission isn’t just another quality management system, it’s the first Design Lifecycle Management™ platform built for medical device teams. Traditional QMS tools focus on storing documents. Fission is built around data, giving you live traceability, automated DHF generation, and a real-time view of your design from concept through launch.
- Design Controls Built In: Manage requirements, risks, and tests in one place. Traceable and audit-ready by default.
- Automated DHF Assembly: Your structured data automatically produces submission documents. Goodbye manual formatting.
- Real-Time Traceability: No more trace matrices in Excel. It’s all linked live.
- Transparent Pricing, No Per Seat Fees: We grow with your team, no surprise costs.
- Consulting Support, Built In: Request help right in the app with Fission Expert™.
With Design Lifecycle Management™, your team moves beyond compliance to design faster, smarter, and with complete visibility from day one.
What Do You Mean Document-Free?
Watch this 2-minute walkthrough to see how Fission works.
Learn More. Build Smarter.
Want to dive deeper into how Fission works, the problems it solves, and strategies for medical device development?
Explore our latest articles on modern product development, quality systems, and innovation strategies. Each post dives deeper into how Fission’s approach helps teams move faster, stay organized, and focus on building great products.
Why the Best QMS for Medical Devices Isn’t Document-Based Anymore
Tired of clunky document-based systems? Discover why the best QMS for medical devices is built on data, not paperwork, and how Fission’s software is changing the game.
Why Medical Device Compliance Doesn’t Have to Be Complicated
Think medical device compliance has to be complex and overwhelming? Think again. Learn why that’s a myth and how modern tools and smarter systems make compliance simpler, faster, and more sustainable.
How to Choose the Right QMS Software for Medical Device Development
Looking for QMS software for medical device development? Discover what to look for in a modern, compliant, and scalable solution and why a data-driven platform beats document management every time.
Early in Your Medical Device Journey? Start Here.
If you’re building your first quality system, or stuck stitching one together, this starter kit will save you time, stress, and second-guessing.
We’ve bundled a set of foundational SOPs, templates, and best practices pulled straight from real audits and regulatory wins. It’s the same framework we’ve used to help early-stage teams hit ISO 13485 and FDA compliance without the bloated overhead.
But when you’re ready to move faster, eliminate rework, and automate your design history file? That’s where Fission comes in.
FAQs
We know you likely have some unmet questions, so we’ve tried to address most of those here, but would be glad to hear from you if you have additional questions you would like to have answered.
What makes Fission different from other eQMS tools?
Most eQMS platforms digitize Word templates and call it a day. Fission replaces documents with structured, traceable data, so you only capture information once and use it everywhere. That means real-time traceability, automated DHF assembly, and no more chasing outdated files across folders.
Who is Fission built for?
Fission is purpose-built for early-stage and scaling medical device teams, especially first-time innovators, quality managers, and engineers launching their first or second product. But it’s flexible enough to grow with you as you scale your processes and team.
Is this just for software (SaMD) or also hardware devices?
Both. Whether you’re building a connected device, SaMD, or hardware-based medical product, Fission helps you manage design controls, risk, and quality documentation in one streamlined workspace. We align to FDA, ISO 13485, IEC 62304, and other key frameworks.
What does pricing look like?
We keep it simple: flat annual pricing, no per-seat fees, no surprise upsells. Whether you’re a team of 2 or 20, you get the full platform and access to our expert consulting support, all under one predictable cost.
Can I talk to a real person if I need help?
Yes. Fission makes it easy to request expert support exactly when and where you need it. Whether you’re stuck setting up your QMS or navigating a tricky design control issue, you can request consulting help directly inside the platform. No jumping through hoops or explaining things twice.
Do you help with setup and onboarding?
Absolutely. We include white-glove onboarding to help you configure the system to your process and get your QMS up and running fast. We also provide guided templates aligned to regulatory expectations, so you’re never starting from scratch.
Is Fission audit-ready?
Yes. Our approach has been tested in FDA and ISO audits. The system ensures traceability, audit trails, and clean documentation from day one without extra manual work. It’s built to support teams that want to pass audits without killing their momentum.
Can I try it before I buy?
We offer a 30-day free trial. We also offer personalized demos and walkthroughs tailored to your team’s needs. If there’s a mutual fit, we’ll explore next steps together. Book a call and let’s talk.
