Author: Regina Fullin
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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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GMP Compliance for Nutraceutical Brands: Where Most Companies Fall Short
GMP Compliance for Nutraceutical Brands: Where Most Companies Fall Short The nutraceutical industry continues to experience remarkable growth, with companies racing to meet consumer demand for dietary supplements and functional foods. However, the industry consistently exhibits the same critical gaps in GMP compliance that can derail even the most promising companies. Here’s what you need… Read more
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What Health & MedTech Founders Should Fix Before Starting M&A Conversations
What Founders Should Fix Before Starting M&A Conversations The M&A landscape for life science has never been more competitive. While strategic acquirers and private equity firms actively seek innovative medtech, pharma, and nutraceutical companies, they’re increasingly selective about the deals they make. In our experience working with companies through acquisition processes, the consistently same critical… Read more
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Red Flags That Kill Medtech and Pharma Deals at the Due Diligence Stage
Red Flags That Kill Medtech and Pharma Deals at the Due Diligence Stage Regulatory compliance issues have derailed countless medtech M&A transactions and pharma deals just as they approached the finish line. In our experience working with acquirers and investment firms over 25+ years, we consistently see the same critical due diligence red flags emerge… Read more
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How Unresolved FDA Findings Affect Deal Valuation
How Unresolved FDA Findings Affect Deal Valuation When pharmaceutical and medical device companies enter acquisition discussions, buyers scrutinize every aspect of regulatory compliance. Among the most critical factors that can derail a deal or significantly impact valuation is an unresolved FDA warning letter. In our experience working with companies across the medtech and pharma sectors,… 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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Why Regulatory Readiness is Essential for Founders Navigating M&A Conversations
As a founder, you’re no stranger to risk-taking… But when it comes to mergers, acquisitions, or divestitures, the stakes are higher than ever. These transactions aren’t just about aligning visions or expanding market share—they’re about managing risks that could impact your brand, your team, and your bottom line. And one of the most critical risks… Read more
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How the CTI Regulatory Readiness Check for Due Diligence Differs from a Compliance Audit
Why Regulatory Readiness is Essential for Founders Navigating M&A Conversations As a founder, you’re no stranger to risk-taking. But when it comes to mergers, acquisitions, or divestitures, the stakes are higher than ever. These transactions aren’t just about aligning visions or expanding market share—they’re about managing risks that could impact your brand, your team, and… 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