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 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...
by Jeremy Moore | Apr 17, 2025 | Software as a Medical Device
SaMD Risk Management is a Golden OpportunityThe Unique Risk Landscape of SaMDThe Power of Software in Risk ManagementCommon Pitfalls in SaMD Risk Management (And How to Avoid Them)1. Waiting Too Long to Address Risks2. Treating Risk as a One-Time Task3. Siloed Risk...
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 | 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 | Jan 22, 2025 | Software as a Medical Device, Compliance and Regulatory Guidance
Are You Leveraging the Right SaaS Tools for Medical Device Startups in 2025?The Role of SaaS tools for Medical Device Startups in 2025Essential SaaS Categories for Medical Device StartupsQuality Management Systems (QMS)Regulatory and Compliance ToolsProject Management...
