FEATURED EDITORIAL

US flag capitol hill-GettyImages-1314505420 Navigating FDA Regulatory Changes: Policy Shifts, Deregulation, Restructuring, And Future Oversight

Recent shifts within the U.S. FDA reflect an increasingly complex tension between scientific rigor and accelerating political and economic pressures. Here are the newest developments and emerging focal points.

INDUSTRY INSIGHTS

  • Tubing Cutter How-To-Guide

    The IDEX Polymeric Tubing Cutter provides clean, even cuts for various tubing types and includes simple blade replacement instructions for long-term precision and safety.

Turning PFAS Challenges Into Opportunities

Medical device makers face growing global pressure to eliminate PFAS. Embracing circular design and innovation offers a path to compliance, sustainability, and supply chain resilience.

Ensure Safety And Compliance With A Guide To Sterilization Validation

Sterilization validation is vital in pharma and medical device manufacturing to ensure product safety and regulatory compliance. Explore essential principles, best practices, and frameworks for effective implementation.

Specific Sterilization Method: Best Practices And Common Pitfalls

Validating sterilization methods like steam, VH₂O₂, and EO is essential for safety and compliance. Learn best practices, avoid common pitfalls, and optimize your validation strategy effectively.

What Is A Bowie-Dick Test And Why Is It Important?

Effective sterilization is vital in pharma and medical device manufacturing. Discover how the Bowie-Dick test ensures vacuum sterilizer performance, safeguards patient safety, and strengthens your sterility assurance program.

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.

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.

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.

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

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.

B. Braun’s OEM Division delivers complete contract manufacturing capabilities for a multitude of markets including surgical, pharmaceutical and biotech. With three global divisions (Europe, Asia-Pacific and North America), B. Braun’s OEM Division offers wide-ranging and complementary capabilities resulting in new products, expanded production, cost efficiencies, and country-specific knowledge.

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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