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FEATURED EDITORIAL

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Medical device manufacturers with regulatory plans in Latin America often treat translation as a procurement task. But is the translated document usable by the regulator and other key entities in the country in question?

CSV Assumes The AI System Sits Still — It Doesn't.

The computer system validation playbook was written for software that holds its shape. AI doesn't. Validating it has to become an act of governance.
Medical Device Licensing Timelines In India To Shorten Under Proposed Amendments

India’s Ministry of Health and Family Welfare has proposed amendments to the Medical Devices Rules 2017 that will shorten manufacturing license timelines while preserving quality, safety, and performance requirements.
When ANVISA's Clock Runs Out

In June, Brazil's ANVISA released a batch of clinical trial petitions because its review deadline had expired without a decision. Take a closer look at what medical device companies should know.

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INDUSTRY INSIGHTS

Advancing Biopsy Device Performance Through Precision Overmolding And Assembly
Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

Six Key Challenges When Precision Has To Scale

Early design alignment resolves tolerance stack-ups, controls mechanical variation, and maintains sample accuracy. Navigating process validation and automated assembly accelerates commercialization.

POC Diagnostics: 4 Considerations For Bridging The Gap From Development To Commercialization

Scaling point-of-care diagnostics requires integrating microfluidics, chemistry, and automated assembly early in development. Aligning these pillars reduces risk and speeds time-to-market.

Planning For Scale Up: Building For Long Term Flexibility

Decisions made during clinical manufacturing have lasting consequences at commercial scale. This article examines how fill/finish equipment choices shape long-term flexibility, throughput, and operational continuity.

Minimizing Particulate Risk: Designing For Control

Effective particulate control in aseptic fill/finish operations requires coordinated design decisions spanning airflow configuration, static mitigation, transport mechanisms, and closure handling.

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SOLUTIONS

Medical Device Supply Chain Management (Metals, Electronics)

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.

Standard Solutions and Containers

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.

Quality Management System (QMS) For Drug Manufacturing

The #1 QMS In Life Sciences Puts You in Complete Control

MasterControl Quality Excellence is trusted by 1,100+ customers — from startups to global enterprises — to bring quality products to market faster.

It's time to close the loop on quality—from quality event management to document management and training—and see how MasterControl quality management system can transform your business today.

GettyImages-966826582 data, research, analytics

Technology Excellence Centers

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

XPLAN CCG Lens Series

The Melles Griot XPLAN Lens Series fluorescence microscope imaging systems enable the rapid development of breadboard instruments for next-gen sequencing, proteomics, and spatial biology applications.

Sensors Unlimited - GL2048-LineScan-Product-Image

High-Resolution, High-Speed SWIR Linescan Camera @ 147 kHz: 2048R

The High Resolution 2048R SWIR camera with capture rates of 10,000 to 147,000 lines per second for Spectral-Domain Optical Coherence Tomography.

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FEATURED SUPPLIERS

Accumold

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

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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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