Last week, the U.S. Food and Drug Administration (FDA) released three new draft guidances to strengthen the 510(k) program and to advance the safety and effectiveness…
Artificial intelligence (AI) is changing the world and the medical device realm, but in reality, it is a simple word: automation. In this blog post, we…
On June 14, 2023, the FDA released their final updated guidance document on the Content of Premarket Submissions for Device Software Functions. The document is the…
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…
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…
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…
What is a Medical Device Report? Medical Device Reports (MDRs) are publicly accessible documents resulting from an event that manufacturers or importers become aware of and…
Medical devices have traveled a long path throughout the past century, and we certainly believe that there are many more miles to go in this ever-evolving…
Medical Device companies are keenly aware of the difficulties and confusion that can surround medical device 510(k) and De Novo filings. With the Voluntary eSTAR Program,…
European regulations require manufacturers to create and maintain a technical file as a prerequisite to submitting a Declaration of Conformity, allowing products to be CE marked.…