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FEATURED EDITORIAL

Building The AI-Enabled Medical Device QMS For European Compliance

Let's take a closer look at how AI-enabled medical devices and their QMS should be compliant with the EU MDR and the EU AI Act while also adhering to applicable ISO standards.

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.
The Synthetic Control Mirage: Why Your Medtech RWD Strategy Will Fail In Latin America

Regulators are actively encouraging medtech companies to use real-world data and synthetic control arms. Here's why this is currently incompatible with Latin America's fragmented RWD infrastructure, though this will change in the years ahead.
Conducting A Medical Device Stability Study: A Practical Guide

Stability studies measure how medical devices respond to environmental stresses such as temperature, humidity, light, and time. Let's take a closer look at designing and conducting a stability study.

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INDUSTRY INSIGHTS

Safeguarding Biologic Integrity Through Enhanced Component Compatibility
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.

Optimizing Syringe Performance For Reliable Drug Delivery

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.

Maintaining Sterility Through Precise Component Design And Manufacture

Prioritizing high-quality component design and manufacturing excellence can mitigate risks, ensure long-term container closure integrity, and avoid the costly delays associated with non-compliance.

Extractables And Leachables: A Critical Part Of CCS Under EU GMP Annex 1

Managing chemical migration from packaging and process equipment is essential to protect patient safety, maintain drug stability, and ensure regulatory compliance.

FAQs On The Revised EU GMP Annex 1: Volume 7

Modernize your sterile manufacturing approach. Explore essential insights on contamination control strategies, risk management, and barrier technologies to ensure full regulatory alignment.

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SOLUTIONS

Standard Solutions and Containers

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.

GettyImages-966826582 data, research, analytics

Technology Excellence Centers

Comprehensive analytical and device testing services are available for injectable drugs, ensuring optimal primary packaging, compliance, and reliability throughout the product development lifecycle.

XPLAN CCG Lens Series

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.

Medical Tubing

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.

Daikyo Crystal Zenith^® Luer Lock Syringe Systems

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.

Assembly And Packaging

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.

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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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