Health Canada, the FDA, and the UK’s MHRA collaborated in 2021 to establish ten foundational principles aimed at promoting good machine learning practices (GMLP). These principles…
Machine learning (ML) revolutionizes the medical field by enabling faster disease detection, more accurate diagnoses, and personalized treatments. These advancements rely heavily on the vast amounts…
As we step into the new year, we asked our team members to share their insights by forecasting five daring trends in medical device quality for…
What is SaMD? SaMD stands for Software as a medical device. Software as a medical device is any software intended to be used for one or…
CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part of…
The medical device market in the Asia-Pacific region has been growing year by year, with a 6.8% CAGR [1] due to an increase in the number…
The Final Clinical Decision Support (CDS) Guidance, describes the FDA’s regulatory approach to Clinical Decision Support (CDS) software functions. Suffice it to say that much of…
Over the past decade, interest in innovating and commercializing medical devices has significantly increased. In the current trend of MedTech, Software as a Medical Device (SaMD)…
The trend of the software industry has been evolving throughout the years. In the past, projects were mainly about digitalization, rule based automation, and local server…
Software as a Medical Device (SaMD) is no longer an emerging vocabulary in 2022. With the rapid development of medical digitalization, medical devices are no longer…