Category: Quality
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Clinical Evidence Requirements for Medtech: What You Need and When
Medical device companies face a complex landscape when determining their clinical evidence requirements. The path forward depends on multiple factors including device classification, predicate devices, and regulatory pathway. Understanding these requirements early in development can mean the difference between a smooth regulatory submission and costly delays. This oversight can derail product launches and strain resources… Read more
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Structure/Function Claims
Structure/Function Claims: What You Can and Cannot Say on Your Label When marketing dietary supplements, the line between permissible claims and regulatory violations can seem razor-thin. Structure/function claims represent one of the most powerful tools in your marketing arsenal, when used correctly. However, missteps in this area can trigger costly FDA enforcement actions and FTC… Read more
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The Difference Between a Compliance Audit and a Regulatory Readiness Check
The Difference Between a Compliance Audit and a Regulatory Readiness Check Understanding the distinction between a compliance audit and a regulatory readiness check is crucial for companies navigating the complex world of FDA regulations. While both assessments evaluate your organization’s adherence to regulatory requirements, they serve different purposes, occur at different stages of your business… Read more
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Why Compliance Is Your Competitive Advantage, Not Your Bottleneck
Why Compliance Is Your Competitive Advantage, Not Your Bottleneck Most founders and operations leaders view regulatory compliance as a necessary evil—a costly hurdle that slows down product launches and drains resources. This mindset fundamentally misunderstands the strategic value of a well-designed compliance strategy. Smart organizations transform compliance from a perceived bottleneck into a powerful driver… Read more
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QMSR vs ISO 13485: What Medtech Companies Need to Know in 2026
QMSR vs ISO 13485: What Medtech Companies Need to Know in 2026 Quality managers in the medical device industry face increasingly complex decisions about which quality management standards to implement and maintain. Two frameworks consistently emerge at the center of these discussions: the Quality Management System Regulation (QMSR) and ISO 13485. Understanding their differences, overlaps,… Read more
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Claims & Ingredients Compliance for Emerging Brands
Claims & Ingredients: Protect Your Brand from Exposure Expo West is a playground of innovation. You walk down the aisles and see bold promises everywhere: “Gut Healing,” “Brain Boosting,” “Zero Net Carbs,” “Sustainably Sourced.” As a founder, you know that these claims are what sell your product. They are the hook that grabs a consumer’s… Read more
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QMSR Readiness for Medical Devices
Preparing for the 2026 Deadline CTI Consulting got its start in the fourth quarter of 2025, with its first assignment to perform a QMSR-focused internal audit assignment I wanted to take this opportunity to provide the insights I had as I performed this audit, so other medical device establishments are able to learn from my… Read more