Medical Device Design & Development


The Intersection Of ISO 13485 And ISO 14971 Under The Proposed FDA QMSR

The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.

The Role Of Failure Mode In ISO 14971:2019’s Hazard-Based Approach

In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.

Why Is Femtech Software Unreliable? + 3 Strategies For Improvement

Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However, a significant number of software-based femtech devices are not reviewed and regulated by the FDA and do not have to prove accuracy. What can we do as medtech developers to improve clinical relevance of these devices and software?

3 Key Benefits Of Deploying Edge AI At The Point Of Care

The point of care is shifting, taking place increasingly outside the hospital setting and moving into patients’ homes. However, cloud computing has some limitations. Edge inference is the practice of deploying machine learning models directly onto devices, allowing the data to be captured and processed at the point of care, rather than in the cloud.


Benefits Of RFID For Medical Device OEMs

This guide will examine why OEMs are increasingly turning to integrated RFID to add value to their products in an increasingly crowded marketplace, and provide key applications for RFID in the medical device field.

RFID For Med Devices: Identifying A Partner

RFID is increasingly being used in medical devices. OEMs can either develop their own RFID solution or partner with an experienced supplier - this guide provides guidance on finding a suitable partner, including what to look for in a supplier, case studies, and proprietary technologies.

The Challenges Of Boomerang Projects In Micro Molding: A Customer Perspective

Boomerang projects in micro molding, where customers' projects return to the manufacturer for rework or modifications, present challenges due to design changes, quality issues, material-related challenges, and poor communication.

Build-To-Print Services For Thin Film Circuit Design And Construction

Knowles Capacitors offers build-to-print services for thin-film circuit design and construction, which can help customers save time and money by reducing the need for in-house engineering and manufacturing resources.


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.

The 1/4" flow APC Series couplings feature a plastic thumb latch, fewer moving parts, and a smooth contoured design to deliver ease-of-use and excellent flow in a compact size. The APC Series has been expanded to include couplings with valves and thumb latch shrouds. A more rugged design on some models adds durability to increase the APC's application range.

The LHL Series of magnetic latching solenoid valves are available in plug-in, face mount, and soft tube ported configurations. Their low power (5.5 mJ per switch), low heat, and small size, make these valves ideal for portable, battery powered medical devices. They’re also an ideal flow control solution for oxygen delivery systems, patient monitors, air calibration equipment, ventilators/respirators, and more.

DVT has developed the first smart image sensor that has high-resolution imaging (640 x 480 pixels) capabilities, combined with network communications (ethernet and fieldbus) that make it the ideal SmartFactory tool

Corry Micronics has developed a 6-way ultra-wide band power divider that has a typical insertion loss of 2 dB with a frequency range from 800 MHz to 18 GHz. The 6 way power divider is rated at 30W CW or 5W CW per input channel. The design is compact and rugged.

The LFN Series Solenoid Valves are 2-way, normally closed, diaphragm valves. These valves feature an isolation diaphragm on an inert housing, making the valves suitable for controlling critical and aggressive fluids.