Medical device types
A sampling of the types of medical devices on the U.S. market, from electrical stimulators to CPAP and BiPAP machines. Most of these are U.S. Class II devices that require a cleared premarket notification (510(k)) to enable them to be marketed in the United States. And most of them have had a product safety recall or correction.
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Medical Device Headlines
DeRoyal Industries, Inc. Recalls Tracecarts
Urgent Class I Recall Notice DeRoyal Industries, Inc. has issued an urgent recall notice for certain Tracecarts containing 16FR Urine Meter Foley under recall by Nurse Assist. Identified by the FDA as a Class I recall, the most serious type, the use of these devices...
Class I Recall for Stay-Safe Catheter Extension Sets and Adapters
Urgent Class I Recall Notice FDA has issued a Class I recall – the most serious type – for certain medical devices manufactured by Fresenius Medical Care. The recall concerns Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters, pivotal components used...
Regulatory Information Management Systems (RIMS)
What Is a RIMS System? A Regulatory Information Management (RIM) system is a software solution designed to streamline and automate the management of regulatory information and processes within the life sciences industry, including pharmaceuticals, biotechnology, and...
Abbott/Thoratec Recalls HeartMate II and HeartMate 3 LVAS
Recall Alert: HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) The FDA has issued a Class I recall, the most serious type, for the HeartMate II and HeartMate 3 Left Ventricular Assist Systems (LVAS) due to potential serious injuries or death...
Quality Management System Regulation – QMSR
Explore how the FDA's newly introduced Quality Management System Regulation (QMSR) is set to redefine compliance standards in the medical device industry, transitioning from the traditional 21 CFR 820 framework.Available in paperback and eBook formats on Amazon. ...
Overview of ISO 13485
ISO 13485, Medical devices quality management systems ISO 13485, Medical devices quality management systems, is an international standard that specifies requirements for a quality management system (QMS) for medical device manufacturers. It also outlines requirements...
FDA Quality System Regulation – 21 CFR 820
QMSR CentralFDA Quality System Regulation – 21 CFR 820 21 CFR 820, also known as the Quality System Regulation (QSR), outlines the requirements for the establishment and maintenance of a quality management system for medical device manufacturers in the United States....
Edwards EVOQUE Tricuspid Valve Replacement System
Edwards EVOQUE Tricuspid Valve Replacement System In a groundbreaking move, the FDA has recently approved the Edwards EVOQUE Tricuspid Valve Replacement System for market distribution. The device was developed by Edwards Lifesciences LLC. This innovative system...
Device Overview – Spinal Cord Stimulation Systems
What Is an SCS System? A spinal cord stimulation (SCS) system is a medical device used to manage chronic pain by delivering electrical impulses to the spinal cord. The system typically consists of several components: Implantable Pulse Generator (IPG) This is the...
Prospera Spinal Cord Stimulation System for Intractable Back Pain
Prospera Spinal Cord Stimulation System FDA has recently approved the Prospera Spinal Cord Stimulation (SCS) System, developed by BIOTRONIK NRO, INC., as a treatment for chronic, difficult-to-manage pain in the trunk or limbs. This implanted system comprises a...