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...
by Jeremy Moore | Dec 31, 2024 | Software as a Medical Device
Why SaMD Trends and Best Practices in 2025 Will Define Your SuccessKey SaMD Trends Shaping the Landscape in 20251. AI and Machine Learning Are Reshaping SaMD Trends2. Cybersecurity Is No Longer Optional—It’s Critical3. Global Expansion Made Easier with Harmonized...
by Jeremy Moore | Oct 16, 2024 | Software as a Medical Device, Product Development
Navigating the Complexities of SaMD Development ChallengesSaMD Development Challenge 1: Regulatory Compliance and Navigating Changing RegulationsSaMD Development Challenge 2: Ensuring Patient Safety and Risk ManagementSaMD Development Challenge 3: Aligning with...
