Tag: quality system

Regulatory pathway analysis–a case study

Medical DevicesMarch 22, 2023

Posted by Rob Packard on March 22, 2023 This article uses a case study example to explain how to determine the correct...

FDA approves LivaNova’s Essenz heart-lung machine

Medical DevicesMarch 10, 2023

The US Food and Drug Administration (FDA) has granted 510(k) clearance to LivaNova’s Essenz heart-lung machine (HLM)...

FDA Guidance on X-Ray Devices and IEC Standards: Enforcement Actinos and Standard Types

Medical DevicesMarch 6, 2023

The new article addresses the aspects related to enforcement actions the authority may take, and also describes the...

Thai Draft Regulation on Quality System: Overview

Medical DevicesMarch 6, 2023

The article provides an overview of the draft law dedicated to the quality system for medical devices intended...

FDA Guidance on X-Ray Devices and IEC Standards: DoC, Certification, and Information Sharing

Medical DevicesMarch 6, 2023

The new article highlights the aspects related to the declaration of conformity, the applicable certification requirements, and also...

Crystal IS and Asahi Kasei announce lifetime characterization data for Klaran LA UVC LED

SemiconductorMarch 3, 2023

News: LEDs 3 March 2023 Tokyo-based Asahi Kasei and its subsidiary Crystal IS Inc of Green Island, NY, USA, which makes proprietary ultraviolet light-emitting...

HSA Guidance on Complaints Handling: Overview

Medical DevicesMarch 2, 2023

The document highlights the key points related to the regulatory requirements for handling complaints associated with medical devices...

FDA Guidance on Medical X-Ray Imaging Devices: Overview

Medical DevicesFebruary 28, 2023

The article addressed the key points related to x-ray medical devices in the context of applicable standards. ...

5 ways to ensure you are a valuable management representative

Medical DevicesFebruary 28, 2023

Posted by Rob Packard on February 28, 2023 This article gives you five ways a management representative can demonstrate value to medical...

ICU Medical Announces Fourth Quarter 2022 Results and Provides Fiscal Year 2023 Guidance

Medical DevicesFebruary 26, 2023

SAN CLEMENTE, Calif., Feb. 27, 2023 (GLOBE NEWSWIRE) -- ICU Medical, Inc. (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical...