Medical Device Design & Development

INDUSTRY PERSPECTIVES

AI In Medical Devices: Meeting The Regulatory Challenge Around The World, Part 1

This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. 

A Proactive 6-Point Approach To Security For Neurotech Developers

There are several key security concerns neurotech developers must address from the outset to ensure both medical and ethical compliance, as well as commercial success. 

How AI Is A Game-Changer For Auditing Compliance And Efficiency

In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever.

Struggling With GxP Systems? There's A DAP For That

A typical life sciences enterprise now has 500+ software applications. A digital adoption platform (DAP) is an overlay to help with user adoption, like an advanced version of the MS Word "paperclip" assistant.

WHITE PAPERS & CASE STUDIES

Ophthalmic Delivery Systems: Drug And Device Testing For Regulatory And Patient Compliance

Explore ophthalmic drug and device testing, focusing on regulatory and patient compliance, including design considerations, testing methodologies, safety, and efficacy for medical device development.

Challenges In Developing Medical Devices From Animal-Based Biomaterials In China

Bovine collagen, valued for biocompatibility and versatility, is gaining attention for medical devices in China as regulatory barriers ease, though safety assurances remain crucial.

Design Testing Strategies To Develop A Drug-Device Combination Product

Leveraging the expertise and experience of a trusted partner can reduce risk and accelerate the time to market for drug-device combination products by creating an optimal Validation Master Plan.

2R Vials And Deep Cold Storage - Determining Mechanical & CCI Performance

Review the implications of this study on the storage of sensitive molecules that require deep-cold storage and learn how 2R Fina glass vials are poised to enhance cold storage practices.

DESIGN COMPONENTS & SERVICES

Where It All Comes Together

The West Contract Manufacturing team provides quality value-added assembly for almost any medical device, drug delivery device or diagnostic device. West contract manufacturing sites have significant and broad-based experience with assembling these types of specialized products. The team’s experience ranges from multi-component, complex assemblies that are manually assembled to high-speed assembly systems built by some of the world’s leading automation integrators.

The 120 Series Solenoid Valves are composed of 2-way, ultra-miniature, magnetically latched solenoid valves. As the smallest solenoid valves in the world, it sets a new industry standard in reducing space, weight and power consumption.

Precision Glass & Optics (PG&O) offers anti-reflective (AR) optical coatings for biomedical and life sciences applications. Ideal for coating on quartz, BK-7, glass, and a variety of other optical materials, AR coatings improve performance in optical systems, increasing transmission and enhancing contrast.

Run classification models directly from your analytical instrument with the Unscrambler X Classification Engine.

The company offers standard and custom optics, including lenses, mirrors, and beam splitters for new and replacement applications in medical, surgical, and dental laser systems.

This series of ultra-low noise signal sources features exceptionally low phase noise, supplementary output at oscillator frequency, and a wide range of output frequencies and multiplication ratios. They provide a range of high-performance building blocks between 200 MHz and 3 GHz.

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