by Jeremy Moore | Feb 19, 2025 | Compliance and Regulatory Guidance
Why IEC 60601 Compliance for Medical Devices Can’t Be an AfterthoughtWhy IEC 60601 Compliance Must Be Built into Your Development ProcessCommon Misconceptions and Hidden Challenges in Meeting IEC 60601 StandardsIEC 60601 Myth #1: IEC 60601 Compliance Is a One-Time...
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...
by Jeremy Moore | Jan 30, 2025 | Compliance and Regulatory Guidance
Is Your Quality Management System Ready for the QMSR Deadline?Understanding the February 2026 QMSR DeadlineKey Changes to Expect with the QMSR DeadlineWhy You Need to Start Preparing Now for the QMSR DeadlineCompliance Isn’t OptionalThe Reality of the TransitionMissed...
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...
