Medical Device Design & Development

INDUSTRY PERSPECTIVES

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    MDSAP Audit Approach Updated From Rev. 6 To 7

    On April 15, 2022, MDSAP Audit Approach AU P0002.007 was updated from version 006 to 007. This article summarizes the changes important for medical device manufacturers to know.

FDA Releases Guidance On Cybersecurity In Medical Devices

的digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).

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

的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.

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

Capture1

ColOSSIS™ from DSM Biomedical is an injectable, settable, drillable putty designed for remodeling bones. It offers improved handling in preparation and delivery and can be mixed with saline, blood, and bone marrow aspirate, allowing for an affordable, fast-remodeling, settable, and drillable biomimetic solution to fracture repair.

Solid State Amplifier for EMC Compliance Testing: 50S1G6

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.

MPC_TOC

MPC Series couplings add ease of use and security to your most critical fluid handling applications. Choose from a full line of connectors and configurations, including pressue sealing caps and plugs in sizes to fit 1/4" and 3/8" tubing.

Engineering And Design Services

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.

Vacuum Switch for MRI, Hyperthermia, and Ablation Equipment

Ducommun’s series of single-pole, double-throw switches covers the DC to 400 MHz frequency range. The switches weigh just 9 ounces and are ideal for integration into MRI machines as well as hyperthermia and ablation equipment.

Low Profile Miniature Positioner: MX80S Stage

This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.

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