by Jeremy Moore | May 6, 2025 | Compliance and Regulatory Guidance, Fission Software, International Regulatory Requirement
Europe Just Threw Down the Gauntlet on Regulatory SubmissionsWhy This Matters to You — Even If You’re not in EuropeWhat MedTech Europe Is Actually Asking For (And Why It’s a Game-Changer)How Fission’s Already Doing This, And Why That’s a Big DealThe Bigger Shift: From...
by Jeremy Moore | Apr 23, 2025 | Compliance and Regulatory Guidance
Why Sterilization Standards for Medical Devices MatterISO 11135: Ethylene Oxide (EO) SterilizationWhy EO sterilization needs a standardKey requirements under ISO 11135:ISO 11137: Radiation SterilizationWhy radiation sterilization needs a standardKey requirements under...
by Jeremy Moore | Mar 25, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements
What is the FDA Q-Submission Program?Why Does the FDA Q-Submission Program Matter?Types of Q-SubmissionsHow to Prepare a Strong Q-SubmissionWhat to Expect from the FDAKey Takeaways: Is a Q-Submission Right for You?Final Thoughts: Get Expert Help for your FDA...
by Jeremy Moore | Mar 19, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements
ISO 13485 vs FDA QMSR: A Shift That Can’t Be IgnoredWhy User Needs Documentation MattersWhat Stays the Same? The Core of User Needs DocumentationWhat’s Changing? Key Differences Between ISO 13485 and FDA QMSRHow to Stay Compliant: Actionable StepsFinal Thoughts:...
by Jeremy Moore | Mar 10, 2025 | Quality Management, Compliance and Regulatory Guidance, Software as a Medical Device
Compliance, but Make It EffortlessThe Problem with Traditional QMS PlatformsHow Fission Changes the Game1. Flat-Fee Pricing: Predictable, Transparent, and Scalable2. A Living, Breathing Compliance System3. Compliance That’s Always-On (Not a Last-Minute Fire Drill)4....
by Jeremy Moore | Feb 26, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements
How ISO 13485 and Customer Satisfaction Go Hand-in-HandWhat Is ISO 13485 and Why Should Customers Care?How ISO 13485 Enhances Customer HappinessImproved Product Quality and ReliabilityBetter Communication and DocumentationFaster Time to Market for InnovationsIncreased...
