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

Setting new standards through breakthrough research and development is at the heart of our business. As the manufacturer of the world's first UV Non-Solarizing (UVNS) optical fiber, CeramOptec® continues to find ways to break down the barriers for simplifying UV spectroscopy and sensing applications.

The LFR Series Micro Inert Valves (MIV) are composed of four different styles of 3-way inert solenoid valves. The valves are designed with different mounting combinations and porting options to allow the highest degree of freedom available for applications demanding high flow rate and small size.

Excelitas Technologies’ C30659 Series includes a Si or InGaAs Avalanche Photodiode (APD) with a hybrid preamplifier, in the same hermetically-sealed TO-8 package, to allow for ultra-low noise operation.

Excelitas’ flashlamp power supplies are ideal for applications involving IPL aesthetic systems, excimer lasers, laser aesthetic systems, Nd: YAG solid-state lasers, pulsed lasers, and dye lasers.

ISO CD 80369-3 was created to define a safe design for an enteral feeding connector. Cardinal Health has helped to develop the ENFit Connection System. This includes a full line of bulk, non-sterile Monoject Purple Oral Syringes featuring the new ENFit connector and a transition connector that allows users to connect to feeding tubes and extension sets with the older design until all components have converted to the new ENFit design.

The MCN-TCP Series of tethered plastic caps are made from a low-density polyethylene to protect medical tubes and ports from contamination.  The caps are designed to be easily removed and reapplied when necessary for applications such as fluid drains.

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