Fission

What Does the FDA’s QMSR and ISO 13485 Alignment Mean for Medical Device Companies? - Fission Learn how the FDA’s QMSR and ISO 13485 alignment impacts medical device companies. Explore key changes, why they matter, and how to prepare for compliance.

When the FDA announced its plan to align QMSR with ISO 13485, it set the stage for a major shake-up in compliance for medical device businesses.

Read more here.

Fission Co-founder and CEO Jeremy More joins TAG 302 at ASQ - World Headquarters!

“I am excited to be a part of the upcoming updates to ISO 19011 and help to forge the future of #Quality #Auditing”

#qualitory

We’ve been quietly building something different—a solution designed specifically for medical device companies, by people who live and breathe this world.

We can’t spill all the details just yet, but here’s the promise: it’ll help you focus less on firefighting and more on innovating.

Innovation isn't just a buzzword, it’s a necessity.

For too long, quality and regulatory systems have felt like hand-me-downs from industries that don’t move at the speed of Medtech.

Complete ISO 13485 Guide for Medical Device Companies - Fission Discover the ultimate ISO 13485 guide and learn how this quality management standard can boost your medical device company's compliance, efficiency, and market success. Get actionable insights on achi...

I talk a lot about compliance, but what if ISO 13485 could actually help you build a stronger, more reliable product? Here’s how.

getfission.com/compliance-a...

Jobs — Forest Neurotech Forest Neurotech

🚀 We’re hiring! Forest Neurotech is looking for a Software Engineering Lead to build the core systems powering our ultrasound neurotech platform.

As a nonprofit FRO, we're advancing science for public good. If you’re excited about neurotech & impact let’s talk. 🌍🧠

forestneurotech.org/jobs

Would love to see if we can help you in your journey.

Unpopular opinion, but AI will only help the average create more average stuff.

It will help create more PowerPoints full of amorphous business lingo and dull content.

It will not shake up the status quo or reinvent a business process.

It will not advance the boundaries of human knowledge.

Hi 👋

I’m ready.

🤣 Definitely recommend you keep going with the long version.

Let’s goooo! 💪

The balance between access and security is a fine line, but in general we need to do better.

Hi!

Over here 👋

You forgot one. 😬

Technology has the great ability to connect but we need more standardization and interoperability in our medical systems and technology. EHR is a great place to start.

Better late than never.

There is so much opportunity for MedTech development using the devices we have around us. We just need a way to make it easier to navigate the regulatory hurdles at the speed of development.

IQ, OQ, PQ Validation for Medical Devices: A Quick Reference Guide for Medical Device Validation - Fission Get a quick, clear guide to IQ, OQ, and PQ validation for medical devices. Learn how Installation Qualification, Operational Qualification, and Performance Qualification ensure compliance, improve qua...

Getting validation right isn’t just about meeting FDA and ISO requirements. It’s about ensuring the safety and reliability of your product—and saving yourself the headache of costly mistakes down the road.
getfission.com/product-deve...