Medical Device Design & Development

INDUSTRY PERSPECTIVES

  • EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused

    The EU's Medical Device Regulation refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in the safety profiles of products.

Your How-To Guide: Developing Advanced Signal Processing Software For Medical Devices

Software is rapidly emerging as a critical product differentiator in the medical device industry. While the software development life cycle described here is widely applicable to a wide range of medical devices, this article focuses on software development for cardiac devices — and more specifically, implementing advanced signal processing software into a cardiac device. 

What’s In Store For EMRs After The Pandemic?

During the pandemic, our industry has realized that electronic medical record (EMR) systems needed some changes. This article discusses the new EMR specifics, including improved operability, advanced analytics, and smooth integration with diverse systems.

Framework Methodologies For Medical Device Usability Engineering

Initial visceral impressions and intuitiveness of use impacts a user's choice of medical device. Addressing the affordance theory means understanding what a user will likely perceive and expect of a proposed design interaction. This article delves into more detail and includes discussion on user interfaces and the user experience process in designing medical devices.

21 CFR 820's New Terminology & Country-Specific Terms For Medical Device Quality

The proposed revision to the U.S. Quality System Regulation (aka 21 CFR Part 820) takes a giant leap toward harmonization with other major global medical device regulations, but some U.S.-specific terms and requirements will remain in effect. This article shares the details and also discusses the impact on inspections.

WHITE PAPERS & CASE STUDIES

How Effective Training Management Can Help You Prevent Quality Issues

Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.

Tech Talk - Fixed Volume Pumps For PCR Testing

Molecular diagnostics is increasingly used for the rapid detection and identification of existing and emerging pathogens. The need for rapid results has required testing to move from normal settings, such as physician’s offices, to smaller, more widespread, and often temporary point of care (POC) locations.

Quality System Metrics That Matter

Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.

Metrics That Matter For Contract Manufacturing

For contract development, manufacturing, and packaging organizations, improving operational flexibility, increasing capacity, shortening lead times, and improving product quality is more important than ever.

DESIGN COMPONENTS & SERVICES

MICROMO’s range of miniature medical device brushed motors has expanded with the addition of two new graphite commutated motors.

The Visco-Jet® Micro-Mixer is composed of 36 critically controlled spin chambers that subject the incoming liquids to a vigorously repeated mixing process. The mixing energy is drawn from the liquids themselves so no electrical or mechanical input is required.

Ocean Optics’ Torus miniature spectrometer delivers scientific grade performance from 360-825nm. Torus has a unique toroidal concave grating design for improved thermal wavelength stability and low stray light. Low stray light, high throughput and excellent thermal stability make the Torus ideal for a wide range of demanding research and OEM applications

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

PTI's expertise and experience are ideal for complex, low-volume injection molding. They are committed to delivering the same precision and price advantages of high-volume production molds. The Low-Volume Production (LVP) molding program utilizes the latest injection molding equipment, including electric injection molding machines with closed-loop processing, and automated material handling systems. PTI also is capable of customized, higher volume production runs.

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.

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