FEATURED EDITORIAL

Are you ready-GettyImages-2259745466 Use Of AI In FDA Inspection Activities: Strategies For Effective Preparation

Are you ready? FDA has begun to implement the use of artificial intelligence in its operations, particularly during inspection activities.

INDUSTRY INSIGHTS

  • Design Freedom Before Steel

    Micro 3D printing helps OEMs validate designs, reduce risk, and accelerate development before tooling, enabling more confident decisions and smoother transitions to production.

Optimizing Packaging Layers: Test Protocols For Device Protection

Understanding how packaging levels interact and support overall package integrity is critical for ensuring regulatory compliance, preserving product performance, and delivering safe, effective devices to patients.

ISO 18562 Series 2024: Essential Updates And Testing Requirements

Taking a proactive approach to compliance can help minimize regulatory risks, avoid submission delays, and ensure continued market access.

Small Joint Implants: A New Era With Medureon™ Bionate

Advances in biomaterials address challenges of small joint implants, improving durability, flexibility, and biocompatibility to reduce wear, enhance motion, and support long‑term patient outcomes.

The Role Of Processing And Supplier Diversification

Optimizing UHMWPE implants requires balancing materials, processing, and sourcing to improve performance, reduce risk, and lower costs in medical device manufacturing.

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.

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.

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.

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Battelle brings together deep experience in bioinformatics, biologics, chemistry and related fields to deliver innovative in vitro technologies with unparalleled accuracy and detection limits — all at unprecedented speed and with significant cost savings.

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

We are component and system-level experts who understand the critical inter-dependencies between microfluidics, fluidics, optics, and integrated sub-assemblies. We specialize in the complete optofluidic pathway to help you avoid project risks and are uniquely positioned to solve even the most demanding challenges in a wide array of applications.

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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