FEATURED EDITORIAL

Map of Republic of Serbia-GettyImages-532960382 The Balkan Puzzle: Using Non-EU States As A "Pre-MDR" Proving Ground For Your Device

The EU's Medical Devices Regulation (MDR) has introduced a new level of rigor. A sophisticated, yet practical, strategy is emerging: leveraging non-EU Balkan countries as a "pre-MDR" proving ground. 

INDUSTRY INSIGHTS

Overmolding: The Basics For Successful Optical Manufacturing

Optical micro overmolding combines micro molding with lead-frame or insert processes to achieve precision, clarity, and integration, demanding early collaboration to ensure manufacturability, performance, and cost efficiency.

FAQs On The Revised EU GMP Annex 1: Volume 6

The revised EU GMP Annex 1 prioritizes a CCS. Learn how to holistically manage microbial, particulate, chemical, and cross-contamination risks to ensure product sterility and patient safety.

Taking A Best Practice Approach To Contamination Control 

Implementing the EU GMP Annex 1 requires a holistic, evolutionary Contamination Control Strategy built on standardization, data analytics, and continuous improvement for a zero-defect mindset.

Laying Supply Chain Foundations That Bring Confidence To Compliance

Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

SOLUTIONS

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.

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.

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

DSM Biomedical delivers a versatile and tunable hydrophilic polymer technology designed for adhesive applications. This technology mimics the proteins of marine mussels when they bond to underwater surfaces.

Manufacture high-quality products at any level of compliance.

FEATURED SUPPLIERS

Accumold® is a high-tech manufacturer of precision micro, small and lead frame injection molded plastic components

Canon U.S.A., Inc., is a leading provider of business-to-business, industrial and consumer digital and optical imaging solutions to the United States, Latin America and the Caribbean (excluding Mexico) markets with an increasing intent for more customized, localized products.

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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