The FDA has recently released a crucial guidance document aimed at aiding the medical device industr...
Due to the outdated agreement between Switzerland and the EU on conformity assessments, Swissmedic n...
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 ...
As a Regulatory Affairs professional, the ability to navigate through a sea of abbreviations and acr...
When it comes to managing and improving your regulatory affairs for medical devices, it's easy to ge...