Medical Device Design & Development

INDUSTRY PERSPECTIVES

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

    欧盟医疗器械监管是指本efit-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

软件正在迅速成为一个关键的产品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的新术语和国家特定的医疗设备质量术语

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

有效的培训管理如何帮助您防止质量问题

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

分子诊断越来越多地用于对现有病原体的快速检测和鉴定。对快速结果的需求需要测试从正常设置(例如医师办公室)转变为较小,更广泛的,通常是临时的护理点(POC)位置。

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

对于合同开发,制造和包装组织,提高运营灵活性,增加容188bet软件下载苹果量,缩短交货时间和提高产品质量比以往任何时候都更为重要。

DESIGN COMPONENTS & SERVICES

Ceramic Core Alumina Heater for Medical and Life Science Applications

Heatron’s ceramic core alumina heater is ideal for dialysis, CPAP, DNA analysis/testing, blood diagnostics, surgical devices, blood/fluid warming, MRI equipment, instrument sterilization, temperature therapy, and vessel sealers.

Pressure Relief Valves (For Plastic)

The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.

Hybrid Connectors

The new Hybrid from Colder eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. It features an easy-to-use twist latch to securely connect everything in one simple motion.

Caplugs Custom Medical Molding

Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.

Optical Design and Engineering

Producing precision optical systems demands a comprehensive opto-mechanical design. II-VI Optical Systems’ team of experienced engineers work collaboratively with your team to design intricate, highly producible systems. We specialize in designing complex systems that are precisely matched with our manufacturing and assembly capabilities to deliver high yields and predictable, optimized results.

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Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.

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