The ASCA Pilot is intended to provide increased confidence in testing results from ASCA-accredited testing laboratories, as well as decrease the burden of individual premarket submissions when manufacturers rely on testing completed by ASCA-accredited testing laboratories.
The FDA recently issued four final guidance documents governing 510(k) regulatory submissions, covering the Special, Abbreviated and Traditional 510(k) pathways, as well as the Refuse to Accept Policy for 510(k)s.
This is the second part of a two-part article exploring various types of prefilled syringes (PFSs) for biopharmaceutical products. Part 1 looked at needle-free and dual-chamber prefilled syringes. Part 2 examines the various aspects of prefilled syringes with staked-in needles and their impacts.
This article answers the question, “how can lean thinking be applied to areas like QARs, QC tests, and document control procedures to remove waste while still adhering to regulations?”
Advances in sensors, smartphones, communications, and analytics give developers new tools to build creative and powerful applications that promise to improve health outcomes and reduce healthcare costs.
As component sizes for medical devices shrink to micron size, conventional machining may not be the most efficient or consistent method for manufacturing. Learn why Micro-MIM is preferred for components with tight tolerances at high volumes.
Sustaining engineering enables the developer to plan ahead, getting the development and design of the device done right the first time, and smoothing the transition to manufacturing. KMC's executive director of engineering, Scott Leon, weighs in on the subject.
The business pain of switching suppliers, both in terms of costs and revalidation time, heightens the importance of making the right decision the first time.
Micromolding requires a high level of intimacy and attention to detail to be successful over the long run, so it’s important to work with micromolder with the capability, scalability, and sustainability to get a product from the design stage all the way to high-quality mass production.
The new FLIR Research Studio is a powerful, yet simple to use software for analyzing how thermal imagery changes over time. Designed to work the way you work, the software makes thermal analysis faster, more convenient, and enables better teamwork. Whether a Windows, MacOS or Linux user, Research Studio provides customers with an easy way to quickly and efficiently display, record, and analyze accurate thermal data on their machine in any one of the available 22 languages.
Zeus offers the FluoroPEELZ™ peelable heat shrink designed with quick and easy peel away capabilities to improve product efficiency and safety, and to accelerate catheter production.
SCHOTT Electronic Packaging and Primoceler Oy have joined forces to expand current hermetic packaging portfolios with pioneering glass micro bonding technology. This process enables the manufacture of vacuum-tight, ultra-miniature electronic and optical devices with superior reliability. This bonding method is based on laser technology and can be completed without any heat or added materials.
MTD Micromolding is solely committed to providing the highest quality micromolding services of advanced medical products. MTD offers their innovative skills in exploring and producing very small, delicate, and intricate components required for advanced medical applications and products such as specialized surgeries, bioabsorbable devices, and implant devices. With a constant demand for newer, smaller, never-before-seen micro medical devices, MTD is also prepared to assist their strategic partners in the development of new solutions.
Canon’s coreless motors are part of the family of dc-motor products that are custom manufactured to achieve the exact speed, power, and currents required for OEM applications. These motors feature a small footprint, high power output, and a low moment of inertial that provides quick response rates and high controllability. They are ideal for many applications including cameras and pumps. Customization and other options are available on request.
The margin for error when it comes to critical components for medical device manufacturing is zero. That's why Accumold ensures robust production processes, extremely tight requirements, and part-to-part consistency.
Starting with the specifications phase, through design, prototypes up to volume production, the MST Group is your reliable partner for turning any of your ideas into a marketable product.
Canon U.S.A., Inc., is a leading provider of business-to-business, industrial and consumer digital and optical imaging solutions to the United States, Latin America and the Caribbean (excluding Mexico) markets with an increasing intent for more customized, localized products.
In the age of connectivity and precision medicine, cybersecurity has taken on critical importance in medical technology development. Software intrusions can risk patients’ health and well-being, as well as their personal data. Device designers must balance these concerns against healthcare provider and patient demand for more connectivity, more access to information, and more ease of use. In this free collection of articles, Med Device Online has collected insights from some of the cybersecurity experts among our editorial contributors.
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