by Jeremy Moore | Sep 17, 2025 | Uncategorized, Compliance and Regulatory Guidance, Fission Software, Quality Management
The Hidden Cost of Choosing QMS SoftwareQuestion 1: Does It Support Continuous Compliance, Not Just Audit Prep?Question 2: How Predictable Are the Costs, Now and as You Grow?Question 3: Is It Designed for Humans, Not Bureaucracy?Question 4: Will It Connect Data and...
by admin | Aug 29, 2025 | Compliance and Regulatory Guidance, Product Development
Traceability Shouldn’t Be This HardThe Trace Matrix TrapWhat True Medical Device Traceability Looks LikeWhy Document-Based QMS Platforms Fall ShortFission’s Approach: Real-Time Medical Device Traceability Built-InThe Impact: What Changes for Your TeamFrom Reactive to...
by Jeremy Moore | Jul 2, 2025 | Compliance and Regulatory Guidance, Fission Software
What If Medical Device Compliance Isn’t the Problem?The Real Problem: Patchwork Systems and Outdated ProcessesThe Myth Busted: Medical Device Compliance Can Be Simple When Built into the ProcessQuiet Shift: Designing for Simplicity from the Start5 Hidden Ways You’re...
by Jeremy Moore | Jun 18, 2025 | Compliance and Regulatory Guidance, Fission Software
Compliance Is Eating Your Launch Time Alive It’s not your product.It’s not your team.It’s the 37 tabs, the shared drive mess, and the spreadsheet circus that calls itself your QMS. If compliance feels like it’s eating your launch timeline alive, this post is for you....
by Jeremy Moore | May 22, 2025 | Quality Management, Compliance and Regulatory Guidance
The Hidden Factor Behind Every 483 LetterCulture Is What Happens When No One’s WatchingIt Starts at the TopMake Quality Part of Everyone’s JobReinforce It in Your Systems and StructuresDon’t Wait for a 483 to Prioritize Quality Culture The Hidden Factor Behind Every...
by Jeremy Moore | May 14, 2025 | Software as a Medical Device, Compliance and Regulatory Guidance
The Future is Here: Digital Twins in SaMDWhat Are Digital Twins in SaMD and How Do They Work?The Big Benefits: Why Digital Twins Matter for SaMD Development1. Faster Development Cycles2. Lower Costs3. Enhanced Accuracy4. Improved Risk ManagementDigital Twins and...
