Compliance, but Make It Effortless

“Audit season is coming.”

But what if it didn’t matter? What if compliance wasn’t a mad dash to pull everything together, but something that just… worked? What if you could achieve audit-ready compliance at all times.

Most medical device companies see compliance as a necessary evil—paper-heavy, time-consuming, and always one step behind. But what if compliance wasn’t just something you had to do—but something that actually made your business stronger?

Traditional QMS platforms don’t make compliance any easier. They’re outdated, slow, and expensive, turning compliance into a constant struggle instead of a seamless part of daily operations.

But what if that changed? What if your QMS was a system that actively supported your growth? What if you could achieve audit-ready compliance at all times.

Fission QMS is built for medical device innovators who want more than just a place to store documents. It’s a data-first, always-on compliance engine designed to keep you audit-ready—without the last-minute scramble.

The Problem with Traditional QMS Platforms

Most medical device companies don’t struggle with compliance because they want to—it’s because the tools they rely on weren’t built for how modern teams actually work.

Traditional QMS platforms:

• Bury critical data in static documents, making real-time insights nearly impossible.
• Charge per user or per product, turning compliance into a growing expense.
• Treat audit prep as a separate, time-consuming process instead of something built into daily workflows.

The result? Compliance becomes reactive, slow, and frustrating.

Fission QMS was built to fix that.

How Fission Changes the Game

Fission QMS isn’t just a compliance tool—it’s a smarter, more scalable way to maintain audit-ready compliance without the usual headaches. Here’s how it transforms quality management:

1. Flat-Fee Pricing: Predictable, Transparent, and Scalable

The Old Way: Most QMS platforms charge per user, per product, or both. As your team and portfolio grow, so does your bill—often unpredictably. It’s a built-in penalty for success.

The Fission Way: One flat, predictable price, no matter how many users or products you have.

Why It Matters:
✅ Budget with confidence—no surprise fees.
✅ Scale your business without scaling your costs.
✅ Focus on innovation, not on managing licenses.

2. A Living, Breathing Compliance System

The Old Way: Traditional QMS platforms treat compliance like a filing cabinet—static documents buried in folders, requiring endless manual updates. Need a real-time view of quality data? Good luck digging through PDFs.

The Fission Way: Fission replaces outdated, document-heavy systems with a dynamic, data-first approach. Instead of just storing compliance records, it actively connects, analyzes, and surfaces critical insights when you need them.

Why It Matters:
✅ Instantly access real-time compliance and quality data.
✅ Make informed decisions faster—with confidence.
✅ Eliminate manual tracking and reduce human error.

3. Compliance That’s Always-On (Not a Last-Minute Fire Drill)

The Old Way: Audit prep feels like a mad scramble—frantically gathering documents, chasing down approvals, and hoping nothing was missed. Compliance becomes an event, not a habit.

The Fission Way: Compliance isn’t something you prepare for—it’s something that’s built into your daily workflows. Fission automates tracking, documentation, and reporting, so you’re always audit-ready. No scrambling required.

Why It Matters:
✅ Never stress about an audit again—compliance is second nature.
✅ Free up time and resources by eliminating last-minute fire drills.
✅ Focus on product innovation, not compliance panic.

4. The Perfect Blend of Software and Human Expertise

The Old Way: Most QMS platforms give you tools—but when compliance questions arise, you’re on your own. Need regulatory guidance? That’s another consultant, another invoice, and another headache.

The Fission Way: Fission combines powerful software with built-in regulatory and quality expertise. It’s not just a platform—it’s like having an expert on your team, ready to help when you need it.

Why It Matters:
✅ Get expert guidance and a powerful QMS—all in one.
✅ Avoid costly consulting fees for routine compliance questions.
✅ Move faster with the right answers at the right time.

5. A QMS Built for Medical Device Innovators (Not Just Any Industry)

The Old Way: Most QMS platforms are generic, trying to serve industries ranging from aerospace to food manufacturing. The result? A clunky, one-size-fits-all system that forces medical device companies to work around it instead of with it.

The Fission Way: Fission is designed exclusively for medical device companies. Every feature, workflow, and compliance framework is built with your specific regulatory needs in mind. No unnecessary complexity—just a QMS that fits seamlessly into your world.

Why It Matters:
✅ No more forcing a generic system to work for medical devices.
✅ Every tool and feature aligns with FDA, ISO, and global regulatory requirements.
✅ Stay ahead of compliance without extra workarounds or manual processes.

The Bottom Line: Your QMS Should Be an Asset, Not an Obstacle

For too long, quality management has felt like a roadblock—slowing teams down with outdated processes and endless paperwork. But compliance doesn’t have to be a struggle.

Fission QMS transforms audit-ready compliance from a stressful event into a seamless, built-in advantage. With flat-fee pricing, a dynamic data-first approach, always-on compliance, and real regulatory expertise, it’s a QMS that works for you—not the other way around.

Ready to see the difference for yourself?
Book a demo today and experience audit-ready compliance made effortless.