by Jeremy Moore | Sep 4, 2025 | Product Development
Why Trace Matrices Fail When Built Too LateWhat It Actually Means to Link Design Inputs to Design OutputsCommon Traceability MistakesStep-by-Step: How to Link Design Inputs to Design Outputs the Right WayWhy Linking Inputs to Outputs Matters for Compliance 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 admin | Aug 12, 2025 | Fission Software, Product Development
The Hidden Risk in Moving FastMedical Device Development Mistakes 1: Waiting Too Long to Build a QMS (or Building the Wrong One)Medical Device Development Mistakes 2: Treating Design Controls Like a ChecklistMedical Device Development Mistakes 3: Using Static...
by Jeremy Moore | Jun 25, 2025 | Fission Software, Product Development
The QMS Crossroads – How to Choose QMS Software for Medical Device DevelopmentOld QMS vs. Modern QMS: Why the Shift MattersWhat to Look for in a QMS for Medical Devices1. Data-First, Not Document-First2. Built for MedTech Compliance3. Integrated PLM...
by Jeremy Moore | Mar 5, 2025 | Product Development, Software as a Medical Device
Overcoming SaMD Development Challenges: What’s Standing in Your Way?Challenge #1: Navigating Complex Regulatory RequirementsChallenge #2: Managing Software Development Under a QMSChallenge #3: Ensuring Cybersecurity & Patient Data ProtectionChallenge #4:...
by Jeremy Moore | Feb 5, 2025 | Product Development, Compliance and Regulatory Guidance
Why Biocompatibility in Medical Device Design MattersWhat Is Biocompatibility in Medical Device Design—and Why Does It Matter?Understanding ISO 10993 and Its Role in Biocompatibility for Medical Device DesignHow to Integrate Biocompatibility In Medical Device...
