FEATURED EDITORIAL

Product researcher, quality control engineer, production line worker-GettyImages-2217587867 Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations

A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”

INDUSTRY INSIGHTS

Optimize Ophthalmic Device Testing For Enhanced Performance, Compliance

Strategic, early testing is essential for ophthalmic device safety, performance, and compliance. Implementing parallel testing and robust data generation shortens timelines and strengthens regulatory submissions.

Key Changes To Biocompatibility And Updates To New FDA Draft Guidance

Review key changes in the upcoming version of ISO 10993-1, regulatory expectations for specific in vitro and in vivo assays, and the FDA's expectations regarding chemical characterization.

Discover How Our Polyurethanes Can Enhance Your Medical Device Designs

Medureon™ is a family of medical-grade polyurethanes engineered for high performance, biocompatibility, and reliability in advanced, critical medical device applications.

Designing Robust Studies To Meet Auto-Injector Performance Requirements

Learn more about the critical tests for ensuring the proper performance of auto-injectors, which are used for a variety of applications ranging from emergency use to treating chronic conditions.

SOLUTIONS

At SMC Ltd. we understand your desire to have a single point of contact for your full medical device. With SMC’s demonstrated strength in IQ/OQ/PQ validation, our network of established and qualified suppliers, and our experience in custom manufacturing, we have the comprehensive resources in place to manage your program from conceptual design to final distribution.

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

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.

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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

Canon's brushless servomotors are compact in size and provide high output power. Two types are offered with quick response and smooth rotation. Various custom options can be incorporated to fit your applications.

FEATURED SUPPLIERS

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply.

MED DEVICE ONLINE CONTENT COLLECTIONS

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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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