FEATURED EDITORIAL
The Cybersecurity Void In Mexico: Why Your FDA-Compliant Device Might Still Fail
While Mexico's health authority, COFEPRIS, has streamlined registration for medical devices, a dangerous shadow regulation has emerged with ad hoc stringent cybersecurity requirements.
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![import brazil-GettyImages-517348988]( "Navigating Brazil's Medical Device Clinical Trial Import Process")
When medtech sponsors plan clinical trials in Brazil, many overlook a critical bottleneck that can delay trial launches by months: the process of importing clinical trial materials.
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![Smart assistant tools technology concept, excellence quality artificial intelligence equipment, application and program-GettyImages-2218177130]( "The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing")
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
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![questions and answers street sign-GettyImages-154945710]( "Why Use Total Organic Carbon Analysis For Cleaning Validation?")
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
INDUSTRY INSIGHTS
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![GettyImages-1087219526-scientist-computer-screen-compliance-sterilization]( "EO Sterilization In Transition: Regulatory Shifts And Industry Impact")
EO Sterilization In Transition: Regulatory Shifts And Industry ImpactEthylene oxide sterilization is transforming. Manufacturers must adopt risk-based approaches and optimized cycles to meet rigorous emission controls and patient safety limits for sensitive populations.
A device's FDA class fails to account for modern cyber exposure. Learn why software architecture and connectivity require independent security assessments to protect patient data and ensure compliance.
Learn about the viscosity-driven limits of dye ingress testing, translating qualitative constraints into a quantitative feasibility boundary shaped by defect size, pressure behavior, and plunger mechanics.
For sensitive biologics and viral vectors, risk extends beyond simple contamination. Utilizing inert barrier films on contact surfaces reduces compound migration and adsorption, maintaining dosage accuracy.
Reliable drug delivery requires precision. Maintaining a robust seal throughout a product’s shelf life is essential to preserve sterility and ensure patient safety during self-administration.
SOLUTIONS
B. Braun provides an array of parenteral pharmaceutical solutions, including those for use in standard IV, irrigation, nutrition, and anti-infective therapy applications. The EXCEL® and PAB® containers and the DUPLEX Drug Delivery Systems feature biologically inert, PVC-Free and DEHP-Free, non-toxic plastic construction for a safe and accurate method of administering IV medication.
Comprehensive analytical and device testing services are available for injectable drugs, ensuring optimal primary packaging, compliance, and reliability throughout the product development lifecycle.
The Melles Griot XPLAN Lens Series fluorescence microscope imaging systems enable the rapid development of breadboard instruments for next-gen sequencing, proteomics, and spatial biology applications.
Nordson MEDICAL is a pioneer and innovator in the design, development, and manufacturing of medical tubing, with decades of experience. We have the broadest, most versatile medical tubing line in the industry. From simple medical tubing to complex, tight-tolerance extruded tubing in a wide range of materials including polyimide tubing, we can meet your needs.
Quick Time To Market, Significantly Lower Risk
Daikyo Crystal Zenith® Luer Lock syringes are designed to fit a variety of standard drug delivery devices, and compared to glass they offer unprecedented strength, durability, and protection.
To help you bring your medical products to market accurately and on schedule, Donatelle provides 24/7 assembly and packaging as part of their suite of integrated services. They have an impeccable track record of meeting project deadlines and maintain a 99%+ on-time delivery rate.
FEATURED SUPPLIERS
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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