Medical Device Design & Development

INDUSTRY PERSPECTIVES

Key QMS Considerations For Your Medical Device Startup

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and provides information to help you make the right decision for your medical device company.

A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices

Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.

Make It A No-Brainer: Designing For Electronic Medical Device Usability

When designing and developing electronic medical devices for users who may be in pain, under duress, or untrained, the goal is clear: make it simple. 

How To Prevent Device Misuse Through Formative Studies

While it isn’t possible to eliminate all cases of misuse, medical device manufacturers can significantly reduce the instances — and chances — through formative studies. This article shares key recommendations.

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

The LPV Series is composed of variable volume, positive displacement pumps available in standard and high performance models. The pumps are designed with a small, light-weight size to permit the pumps to be located where the fluid requirements are needed, reducing the required transport volume of the system.

KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.

The LHD Series by the Lee Company comprises high-density interface solenoid valves ideal for oxygen delivery systems, gas analysis equipment, patient monitors, air calibration devices, gas chromatography devices, and other medical instrumentation with flow control needs and limited space.

The SR series of miniature optical encoders has been designed to fit into motion control devices with limited space, such as robotic arms for surgery, nanopositioning stages, microscopes, and other medical devices.

The Lee Company offers both dispensing and atomizing nozzles that deliver precise droplets or atomized fluid for medical device applications like in-vitro diagnostics, respiratory care, therapeutic care, and drug discovery applications.

The company designs and manufactures plastic optical fiber devices for the transfer of light, data, and images.

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