Digital Health Series – Part 3: Software as a Medical Device Regulated by the EU
Previously, we talked about how the FDA regulates Software as Medical Device (SaMD), in this blog post we will discuss…
The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the Part 1 of the blog post, we explored the regulations relating to medical devices and cosmetic products in…
Ask the Experts: Unleashing the potential: Unveiling the regulatory drivers of the SaMD market in…
Software as a medical device (SaMD) has been used in the healthcare sector for many years, particularly in the space…
The regulatory challenge for determining status between medical devices and cosmetic products with borderline claims…
In the competitive race for innovation and marketing, a manufacturer may develop new technological products with the objective of using…
Regulatory Trends in the Nonclinical Development of Viral Vector-Based Gene Therapies: A Benchmark Analysis of…
As it is often the case with innovative technologies, regulatory agencies are highly demanding in product safety demonstration from those…
Digital Health Series – Part 2: Software as a Medical Device Regulated by the US…
Artificial Intelligence has achieved major milestones in the US, with the FDA granting clearance to the first AI-based software for…
How to Optimize CMC for Successful Cultured Meat Product Development
Cultured meat products are novel in the market, there are no regulatory and CMC guidelines specifically dedicated to them. Therefore,…
Digital Health Series – Part 1: Defining Software as a Medical Device
Recently, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has provided updates to the guidance Software and AI…