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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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Meet Our Contributors

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.

Most Frequently Asked Questions 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

Feasibility Studies And Test Method Development For Container Closure Integrity

A variety of test methods exist to challenge package quality and performance. The goal of a feasibility study is to assure that the right technology and test method are applied to each product application to provide accurate, sensitive, and reliable data for definitive package integrity verification.

Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Self-Contained Biological Indicator For Monitoring Steam Sterilization

MagnaAmp^® is a self-contained biological indicator ampoule for monitoring steam sterilization of liquids in ampoules, large containers, or washer sterilizers.

Non-Magnetic Capacitors: High Q, C0G/NP0, X7R

Components with a copper barrier and a tin finish on top provide a fully non-magnetic component to be used in medical applications where non-magnetic components are required.

Medical Device And Diagnostics Manufacturing Software

Manufacture high-quality products at any level of compliance.

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General Surgery Structures

For applications in tissue reinforcement and wound support, biomedical textile structures made from a variety of materials can help achieve specific biomimetic and compliance requirements.

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FEATURED SUPPLIERS

Nordson MEDICAL

PTI Packaging and Inspection Systems

PTI is a leading manufacturer of inspection equipment and a services solutions provider. We specialize in the development of sensory technologies for container closure integrity testing (CCI), package integrity, and seal quality inspection. PTI’s Life Science CCI services provide regulatory guidance and support throughout the pharma product lifecycle. We serve the Life Science industries encompassing Pharmaceutical, Biotech, & Medical Device.

Leading inspection technologies include High Voltage Leak Detection (HVLD), Vacuum & Pressure Decay, Airborne Ultrasound, and Helium leak testing. These innovations find versatile applications across a wide range of packaging formats, including pre-filled syringes, vials, ampoules, cartridges, autoinjectors, IV bags, blister packs, pouches, and numerous other packaging configurations.

PTI’s non-destructive technologies are designed for applications spanning R&D lab testing, automated inspection, and solutions for technology integration.

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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