This blog will delve into the background of AI/ML and its regulatory impact on the pharmaceutical world.
The MDCG published guidance on medical device software (MDSW) this month that is intended to clarify when devices ...
This blog will give an introductory overview of the FDA’s role with radiation-emitting electronic products.
The modern business landscape is rapidly evolving, and with it, the challenges of workforce management. In this ...
TAA compliance is important to the MedTech industry since you must be in compliance with the act in order to sell ...
In this blog, we will explore the intricate interplay between geopolitics and the pharmaceutical industry, ...
Drug development is an extremely complicated process, both from a technological perspective and a regulatory one. ...
Last week the FDA announced it is establishing a digital health advisory committee to increase its understanding ...
This week the FDA revised its guidance for magnetic resonance (MR) devices. In this blog we will explore the ...
In this blog, we will explore how AI/ML is revolutionizing the medical device industry and the FDA's plans for ...
In this blog we will go over the high-level details of what to expect when you’re inspected by the FDA.
The medical device industry is a dynamic and ever-evolving sector that plays a pivotal role in the healthcare ...