Understanding the FDA Q-Submission Program: Streamlining Regulatory Feedback

by Jeremy Moore | Mar 25, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

What is the FDA Q-Submission Program?Why Does the FDA Q-Submission Program Matter?Types of Q-SubmissionsHow to Prepare a Strong Q-SubmissionWhat to Expect from the FDAKey Takeaways: Is a Q-Submission Right for You?Final Thoughts: Get Expert Help for your FDA...

ISO 13485 vs FDA QMSR: Breaking Down the Key Changes in User Needs Documentation

by Jeremy Moore | Mar 19, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

ISO 13485 vs FDA QMSR: A Shift That Can’t Be IgnoredWhy User Needs Documentation MattersWhat Stays the Same? The Core of User Needs DocumentationWhat’s Changing? Key Differences Between ISO 13485 and FDA QMSRHow to Stay Compliant: Actionable StepsFinal Thoughts:...

ISO 13485 and Customer Satisfaction for Medical Device Companies

by Jeremy Moore | Feb 26, 2025 | Compliance and Regulatory Guidance, US FDA Regulatory Requirements

How ISO 13485 and Customer Satisfaction Go Hand-in-HandWhat Is ISO 13485 and Why Should Customers Care?How ISO 13485 Enhances Customer HappinessImproved Product Quality and ReliabilityBetter Communication and DocumentationFaster Time to Market for InnovationsIncreased...

What Does the FDA’s QMSR and ISO 13485 Alignment Mean for Medical Device Companies?

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...

Understanding IEC 62366 for Medical Devices: Designing for Usability

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...

Overview of the 3 FDA Medical Device Classes: Which One Does Your Product Fit Into?

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...