In response to the ongoing global health crisis, Malaysia has taken a significant step forward in th...
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A Guideline for the Withdrawal and Recall of Medical Devices and In Vitro Diagnostic Devices from th...
In a significant move towards ensuring the safety and quality of medical devices in circulation, the...
The FDA has recently released a crucial guidance document aimed at aiding the medical device industr...
We just passed our ISO9001 Recertification audit, and we are proud to share BSIs' opinion.
On July 5, 2023, TMDA released a draft of Guidelines for handling unfit Medical Devices and diagnost...
Eric Partaker makes some interesting statements about AI in his recent linked post. The two most rel...
Clinical evaluation of a medical device aims to show that the device offers more benefits and poses ...
Recessions can have far-reaching consequences across various industries, often resulting in signific...
In the world of regulatory affairs, success stories often unfold in unconventional ways. While many ...