CBRN
The article provides a brief overview of a special regulatory framework introduced for certain in vitro diagnostic medical devices.
Canada
This article highlights he current regulations for medical devices in Canada, the process of registering compliant devices, potential changes being considered, and the potential impact on stakeholders. Table of Contents The use of medical devices is essential in...
Medical Devices
This article highlights he differences between intended use and indications of use, along with their significance. Table of Contents In the highly regulated world of medical devices, precision in terminology makes a significant impact. It is important for preparing...
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...
Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
