TGA Guidance on Essential Principle 13B: Compliance
The new article provides further details regarding the particular approach to be followed in order to achieve and maintain compliance with the relevant regulatory requirements.
The new article provides further details regarding the particular approach to be followed in order to achieve and maintain compliance with the relevant regulatory requirements.
The new article elaborates on the specifics of the regulatory approach medical device software products are subject to.
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...
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...
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...