Oct 12, 2023
CDRH
This article describes Software Based Medical Devices and their key regulatory considerations. Table of Contents Software is now a crucial component of every product as technology continues to develop all elements of health care. It is widely integrated into digital...
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Oct 4, 2023
GMDN
This aticle highlights the importance of Medical Devices in the healthcare industry highlighting their key uses, developments and emerging technologies in the sector. Table of Contents Over the past few decades, there has been a significant evolution in medical...
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Sep 20, 2023
FDA
The new article addresses the aspects related to modifications to existing medical devices already placed on the market and allowed for use in the US. The document describes in detail various types of changes and explains the way their regulatory status should be...
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Aug 11, 2023
IMDRF
The new article describes in detail additional controls to be implemented with respect to medical devices that are no longer supported by their manufacturers. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary association of...
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Aug 11, 2023
IMDRF
The new article highlights the aspects related to the “End of Support” stage of the total product life cycle and outlines the key points to be taken into consideration at this stage in order to ensure the proper performance of medical devices as well as the safety of...
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Jun 27, 2023
IMDRF
The new article highlights the aspects related to the limited support stage of the total product life cycle and provides recommendations to be followed by the parties involved. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary...
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