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 | Jan 15, 2025 | US FDA Regulatory Requirements, Compliance and Regulatory Guidance
How the FDA’s QMSR and ISO 13485 Alignment Will Reshape Medical Device CompaniesUnderstanding the Shift: Why the FDA’s QMSR and ISO 13485 Alignment is HappeningKey Changes in QMSR: What Medical Device Companies Need to KnowWhy These Changes Matter: The Impact on...
by Jeremy Moore | Jan 8, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements
Understanding IEC 62366 for Medical DevicesWhat is IEC 62366 for Medical Devices, and Why Does It Matter?Why Usability Matters in Medical DevicesThe IEC 62366 for Medical Devices Process: Step-by-Step Guide1. Prepare Use Specification2. Identify Usability-Related...
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 | Dec 26, 2024 | Quality Management
Quality is the Secret Sauce, Not the SlogKey Building Blocks for a Quality CultureActionable Strategies to Foster a Quality CultureSustaining a Culture of QualityThe Competitive Edge of a Quality Culture Quality is the Secret Sauce, Not the Slog Some companies chase...
