by Jeremy Moore | Jun 11, 2025 | Quality Management
The Hidden Burden of “Being Compliant”What Is the “Document Trap”?Why Traditional QMS for Medical Devices Make It WorseThe core problem? Structure.Compliance Shouldn’t Be This HardWhat a Data-Driven QMS for Medical Devices Looks Like (And Why It Changes Everything)The...
by Jeremy Moore | Jun 4, 2025 | US FDA Regulatory Requirements
The Harsh Reality of First Time FDA SubmissionsCommon Reasons First Time FDA Submissions FailLessons Learned: How to Avoid These MistakesThe Cost of Getting It Wrong (and the Value of Getting It Right)The Reality CheckThe Ripple EffectThe Path ForwardHow Fission...
by Jeremy Moore | May 28, 2025 | Uncategorized, Software as a Medical Device
Top SaMD Trends in 2025 That are Shaping the Future of SaMD and Medical Devices1. AI Isn’t Just a Buzzword Anymore, it’s a Backbone2. Real-World Evidence Is the New Clinical Trial3. The Cloud Becomes the Command Center4. Global Regulatory Harmonization (Finally?)5....
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...
