Oct 11, 2023
Asia
This article highlights key steps and considerations for medical device companies to establish effective design controls. Table of Contents Design controls are a crucial aspect of the medical device development process.They ensure that medical devices are safe,...
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Oct 10, 2023
Asia
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
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Oct 6, 2023
Uncategorized
This blog highlights the importance of regulatory compliance for medical device manufacturers, roadblocks and key steps to navigate through them. Table Of Contents: Medical devices play a crucial role in the healthcare ecosystem, aiding in the diagnosis, treatment,...
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Oct 5, 2023
FDA
This article highlights 21 CFR part 11, its scope, applicability and effective ways to maintain regulatory compliance. Table of Contents 21 CFR Part 11 is a regulation introduced by the United States Food and Drug Administration (FDA) that sets forth the criteria...
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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 28, 2023
Asia
The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. Table of...
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