Medical-Device Analysis: Drug Coating, Defect, Failure, Metrology

Medical-Device Analysis: Drug Coating, Defect, Failure, Metrology

We specialize in medical device defect, failure, and metrology analysis, delivering critical insights to help businesses ensure the safety, performance, and regulatory compliance of their devices. Using advanced techniques like SEM, EDX, XRPD, ICP-MS, FT-IR, GC-MS, and others, we identify issues such as drug coating inconsistencies, microscopic cracks, alloy mix-ups, contamination, or incompatibilities that can derail a 510(k) submission or lead to costly recalls. Our comprehensive testing covers drug-coated medical devices—including stents, catheters, and combination products—focusing on coating thickness, consistency, stability, and drug release profiling, ensuring your product meets FDA and USP requirements. We design multi-technique, cGMP-compliant data packages to evaluate extractables, leachables, particulate cleanliness, and material behavior under various conditions, helping you align with regulatory standards and maintain your competitive edge. With rapid turnaround times and precise, actionable results, we empower you to resolve failures, refine processes, and bring high-quality medical devices to market with confidence.