Medical Device Design & Development

INDUSTRY PERSPECTIVES

Expanding A Bow Tie Risk Analysis Model Using Relational Risk Analysis

Relational risk analysis can be used to enhance and expand a bow tie analysis in the pharma and medical device industries to more effectively analyze risks as relationships between mechanisms and events.

Tips From A Biomedical Engineer For Medical Device Innovation And Compliance

Every new medical device feature must live within a quality management system that tracks design control, risk management, and post-market performance. Waiting until design freeze to loop in your quality and regulatory experts invites costly rework and setbacks.

Understanding The Impact Of An RMP On Patient Risks Using Relational Risk Analysis

Using relational risk analysis, let's take a closer look at risk management plans for identifying and managing adverse reactions for administering a new therapy to a patient.

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. 

WHITE PAPERS & CASE STUDIES

Laerdal Error-Proofs Medical Kit Assembly With AI-Powered Vision Verifications

Discover how Laerdal Medical implemented an automated kit assembly solution that enhances quality control and supports continuous improvement through real-time monitoring and visual documentation.

Leverage Apps To Reduce Line Changeover Time From 14 Days To 3

A global biopharma leader modernized its complex equipment changeover process using an innovative platform to achieve faster execution, fewer errors, and greater visibility through digitized, validatable SOPs.

Eurofins Medical Device Services Expands US Portfolio With New Ethylene Oxide Sterilisation Solution

Eurofins’ San Jose EO sterilization site offers fast, high-quality sterilization services for medical devices, ensuring compliance with FDA, cGMP, ISO 11135, and new EPA regulations.

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 COMPONENTS & SERVICES

The Lee Company now offers a series of Luer Tee fittings with relief valves fit into the Tee. Three models of different sizes are particularly useful for syringe driven systems where maximum force is required. All fittings are 100% flow tested for consistent batch-to-batch performance, and to make sure all parts are within performance tolerance.

Hamamatsu’s line of X-ray flat panel sensors feature high sensitivity, high frame rates, and high resolution. This makes them ideal for integration into dental X-ray systems, CT scanners, digital radiography systems, and X-ray systems for core needle biopsies.

This automation table combines a mix of linear servo motor and ballscrew drive technology  and comes in a small size for light loads and shorter travel distances. It has an X-Y work area to 600mm x 300mm and a max load capacity of 5 kg.

Flexan uses medical grade silicone for implantable and disposable medical devices that require high performance and safety characteristics whenever in contact with a human body. With no side effects and the ability to be sterilized, this material meets or exceeds all USP Class VI test requirements. It will also retain its shape under pressure and temperature extremes.

AR’s solid state amplifiers are often used in medical EMC compliance test efforts. The 50S1G6 is a class A solid state amplifier which provides 50 watts of output power from 0.7 to 6 GHz.

The Proto Labs CNC turning process is capable of producing custom prototypes and end-use production parts in as fast as one day and is best used for creating parts with cylindrical features, as well as parts with axial and radial holes, flats, grooves, and shots.

LATEST HEADLINES