More than just another eQMS.
Fission® Design Lifecycle Management™ launches medical devices with confidence — powered by data, not documents.
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
Up to 90% of medtech startups never commercialize due to lack of direction or early application of compliance requirements.
Fission flips the model:
- Data first architecture gives you live traceability across requirements, risks, and tests
- Documents are generated on demand from real-time data
- No more formatting. No 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.
Eliminate The Confusion With Data-Driven Product Development
See the Ripple Effect Instantly
One change updates everywhere. Requirements, risks, tests, and labels stay perfectly in sync.
Work in Live Data, Not Static Docs
No more digging through outdated files. Everything links together in real time.
Always Audit-Ready
Submission-ready documents generate automatically, keeping you prepared without the scramble.
Cut Waste, Save Money
No duplication, no rework, no last-minute chaos — just clean, efficient progress.
Built For Founders
Bringing a medical device to market is complex. Fission gives founders the clarity, tools, and support to move from concept to commercialization with confidence.
- Design Lifecycle Management™ – Manage product development end-to-end, from concept to commercialization.
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Fission Expert™ – Flat-fee regulatory + technical support built in.
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Transparent Pricing – No per-seat fees. Scale your team without penalty.
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Data-Driven Traceability – Faster DHF assembly, fewer design cycles, less risk at submission.
The Cost of Getting it Wrong
90% of startups fail without early compliance & direction.
Unclear requirements = months of delay + $$$ lost on rework.
A single FDA 483 response = ~$250K + months of delay.
Fixing poor development is 2–3x more expensive than getting it right.
Fission® helps you get it right the first time.
What Fission® Offers
The right fit at every stage. Other systems force you to fit their mold. Fission flexes to your stage of growth, whether you’re DIY-ing, guided, or white-glove.
Fission Design Lifecycle Management™ (DLM) software can help wherever you or your company are today. Its features include:
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Design Controls |
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| User Needs | Verification and Validation | Launch Activities | |
| Risk Management | Design Transfer | Post market surveillence | |
| Product Requirements | Design Reviews | Business Deliverables | |
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QMS Processes |
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| Document Control | Training | Supplier Management | |
| Management Review | Complaint Management | Audits | |
| Calibration & Maintenance | Non-Conformance | CAPA | |
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Implementation Support |
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| Setup | Training | Best Practices | |
Meet Fission Expert™
Software is just the start.
For many medical device teams, the platform alone isn’t enough. They need regulatory expertise, strategic guidance, and hands-on support to accelerate development and reduce risk. That’s where Fission Expert™ comes in.
Fission Expert compliments the Fission platform. With Fission DLM+ you’ll have on demand access to real humans to accelerate your development while maintaining a value added QMS compliance program. Whether its defining your regulatory pathway, helping to draft user needs, or handling a CAPA Fission Expert provides built in expertise.
From quick compliance guidance and audit support to full DHF creation and submission readiness, Fission Expert scales to meet your needs. Whether you just need occasional support or want a white-glove partner to manage the heavy lifting, Expert keeps your team moving fast, without ever leaving the platform.
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.
DIY Medical Device Development: Why More Founders Are Taking the Hands-On Route with Fission
Discover how Fission is empowering founders to take the DIY route in medical device development with guided software and educational tools. Learn how to define user needs, meet compliance requirements, and accelerate your path to market.
Who Is the Fission DLM Free Version For? (And What You Can Do With It)
Discover who benefits most from the Fission DLM free version and what’s included in it. Learn how startups, consultants, and innovators can use Fission’s free plan to manage user needs, risk, and product requirements, all in one compliant platform.
What is Fission Expert? Consulting Built for Medical Device Companies.
Discover what is Fission Expert and how it combines consulting with software to help medical device companies stay compliant, accelerate growth, and reduce regulatory surprises.
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 DLM™ different from other eQMS tools?
Most eQMS platforms digitize Word templates and call it a day. Fission DLM™ 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 DLM™ built for?
Fission DLM™ 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 monthly 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 DLM™ 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 see it before I buy?
