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 | Nov 6, 2024 | US FDA Regulatory Requirements
Understanding FDA Medical Device Classes: Which One Does Your Product Fit Into?Why FDA Medical Device Classes MattersClass I Devices: Low Risk, Minimal OversightClass II Devices: Moderate Risk, More Stringent ControlsClass III Devices: High Risk, Maximum OversightHow...
by Jeremy Moore | Oct 23, 2024 | International Regulatory Requirement, US FDA Regulatory Requirements
Why a US Agent for FDA Submissions is essential: From 510(k) to PMAWhat Is a 510(k) Submission?The Role of a US Agent in the 510(k) ProcessWho Is a US Agent?Responsibilities of a U.S. AgentHow to Choose the Right U.S. Agent for Your 510(k) SubmissionRegulatory...
by Jeremy Moore | Oct 2, 2024 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements
The 510(k) Submission Process: A Critical Pathway to FDA ClearanceUnderstanding the 510(k) Pathway: What Is It and Who Needs It?Types of 510(k) Submission Process and When to Use ThemThe Step-by-Step 510(k) Submission ProcessTips for a Smooth 510(k) Submission...
by Jeremy Moore | Sep 4, 2024 | US FDA Regulatory Requirements, Compliance and Regulatory Guidance
Introduction to FDA Breakthrough Device Designation?What is the FDA Breakthrough Device Designation?Benefits of FDA Breakthrough Device DesignationAccelerated Development and ReviewPriority Review and Interaction with FDAReimbursement AdvantagesMarket...