The COVID-19 pandemic has had a significant impact on the medical device industry. During this time, many medical devices became commercially available under enforcement policies, and…
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CDRH finally issued Draft Guidance on Pre-determined Change Control Plans for AI/ML-enabled medical devices or AI/ML-enabled device software functions, including software functions that are part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 EU Medical Device Regulations (MDR) has been a looming, dark cloud of change for Medical Device Manufacturers. Whether the discussion is focused on the new…
What Do Your Annual Internal Audit and Annual Physical Have in Common? They both roll around once a year, and both are typically dreaded. Your annual…
Recommended Practices for Software-Contained Device Manufacturer Why Cybersecurity for Medical Devices? As more medical device software is released to the market, information exchange and integration between…
When medical devices are user-friendly there is a higher probability for users to continue using the device for clinical or personal purposes and highly recommend the…
What is the IVDR? An Overview The EU IVDR 2017/746 is the European Union In Vitro Diagnostic Regulation. This regulation is replacing the EU IVDD In…
With the new year upon us, we asked our Founder/President, Kyle Rose, and our General Manager (Taiwan Branch), Andrew Wu, to peer into their respective crystal…
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…