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
FDA Alert: Abiomed Impella Blood Pump Controller
Abiomed Impella blood pump controllers Controller May Fail to Detect Device Abiomed has issued an urgent safety notice for its Automated Impella Controller (AIC) due to a potentially serious issue where the system may fail to detect the Impella blood pump when...
FDA Alert: Baxter Recalls Spectrum Infusion Pumps
Baxter Spectrum Infusion Pump Alert Date: July 2025Device: Sigma Spectrum Infusion System (V6 and V8 Platforms)Manufacturer: Baxter HealthcareIssue Type: Urgent Medical Device RecallFDA Status: High-risk; active monitoring in progress The FDA has issued an early alert...
How Unsafe Medical Devices Can Slip Through the Cracks
Healthcare professionals and the device industry share responsibility for timely adverse event reportingGlobal device market withdrawals not always followed in US In a world of global trade and instant communication, you might assume that a medical device deemed...
Study Reveals Delays in Medical Device Adverse Event Reporting
Healthcare professionals and the device industry share responsibility for timely adverse event reportingLapses defeat the purpose of adverse event reporting A recent study published in the British Medical Journal has spotlighted a troubling trend: many medical device...
QSR-to-QMSR Paper Gap Audit
Is Your Quality Management System Ready for QMSR? As FDA’s transition from the QSR to the QMSR approaches, many medical device manufacturers are discovering that “substantially equivalent” doesn’t mean “completely aligned.” Even companies with solid QSR documentation...
Postmarket Surveillance – from QSR to QMSR
How QSR Postmarket Surveillance Will Evolve Under the QMSR As medical device manufacturers transition from the FDA’s Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), one area undergoing significant change is postmarket...
Medical Device Labeling
In the world of medical devices, proper labeling isn't just a regulatory requirement, it is a vital component of patient safety, product usability, and market access. Whether you're a manufacturer navigating FDA regulations, a distributor handling multilingual...
QMSR Clause 8 – Measurement Analysis and Improvement
Using Data to Drive Quality, Risk Control, and Continuous Improvement Clause 8 of ISO 13485:2016 defines how organizations monitor performance, analyze data, and take action to ensure their quality management system (QMS) remains effective. At its core, this clause...
QMSR Clause 7 – Product Realization
ISO 13485 Clause 7 - Product Realization Clause 7 of ISO 13485, titled Product Realization, outlines the structured approach medical device manufacturers must take to design, develop, produce, and deliver devices that meet customer needs and regulatory requirements....
QMSR Clause 6 – Resource Management
Ensuring the Organization Has the Capability to Deliver Safe and Effective Medical Devices Clause 6 of ISO 13485:2016 defines the requirements for providing and managing the resources necessary to implement, maintain, and improve a quality management system. At its...