Taking the extra steps to ensure medical device quality assurance

Here’s how medical device manufacturers can go the extra mile to address regulatory challenges and user needs with comprehensive and purposeful quality assurance systems.

Judith Antler, Eitan Medical

[Image from Unsplash]

Quality assurance (QA) control is a central component of any manufacturing process, ensuring the end product is reliable, safe and of the highest quality. This process is critical in the medical device industry, as faulty devices can have severe patient health implications.

When we consider the current COVID-19 pandemic and the abundance of critical care administered via medical devices, today more than ever, we must aim to ensure our products meet all safety standards and beyond.

Unfortunately, even with the current regulatory policies and systems, there are still recalls and field actions in the medical device industry. Both humans and machines are subject to error, but we must…

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Eitan Medical wins EU clearance for Sapphire infusion pump

Eitan Medical announced that it received European Union Medical Device Recognition (MDR) certification for its Sapphire infusion pump.

Approval for the Sapphire infusion pump, along with its accessories and administration sets, was granted in January 2021, according to a news release. The certification is EU MDR 2017/45.

Get the full story at our sister site, Drug Delivery Business News.

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Eitan Medical lands FDA clearance for infusion pump system upgrade

Eitan Medical (formerly Eitan Group) announced today that the FDA has granted 510(k) clearance to its upgraded Sapphire infusion pump system software Rev15, which includes the infusion pump, administration sets and accessories.

The Sapphire infusion system is the company’s flagship infusion device and is used across the U.S. within alternate sites, homecare markets, emergency medical services and hospitals.

The compact Sapphire infusion pump is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural medication, epidural medication, blood and blood products. It has a color touch screen for intuitive and fast operation, built-in safety mechanisms and technology designed to minimize dosage errors and false alarms.

The most recent hardware and software upgrade adds a number of  improvements, including:

A perineural route intended to support a wider range …
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