Fission
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Fission
@getfission.com
Fission™ enables small and medium-sized medical device companies to efficiently bring to market safe and effective medical technology by providing them with comprehensive regulatory compliance and design control.
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.
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.
getfission.com
January 18, 2025 at 4:04 PM
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
December 13, 2024 at 12:44 PM
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.
December 13, 2024 at 12:41 PM
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.
December 13, 2024 at 12:40 PM
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...
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...
getfission.com
December 13, 2024 at 12:38 PM
Reposted by Fission
🚀 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
Jobs — Forest Neurotech
Forest Neurotech
forestneurotech.org
December 3, 2024 at 9:12 PM
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.
December 3, 2024 at 6:40 PM

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...
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...
getfission.com
December 2, 2024 at 8:28 PM