Medical Devices

Earlier this year, the Department of Health and Human Services proposed exempting 84 types of Class II devices from 510(k) requirements, which stemmed from the relaxed regulations for the COVID-19 public health emergency. After reviewing adverse event data from both...

One of the major purposes manufacturers incorporate AI or ML in their applications is to ease software computations and to predict precise results. I think compared to any other application, a medical application requires a lot of precise computations and...

The FDA’s adverse event reporting system (FAERS) is a web-based tool that allows users to interactively search and query adverse event data. The tool intends to provide users access to adverse event reports submitted by the pharmaceutical industry, health care...

Real World Evidence (RWE) is playing an increasingly significant role in the medical device industry. The FDA has recently pushed for an increase in using RWE to support regulatory submissions, in an effort to promote public health. To define what...

When I was working on a web application as a developer, I always noticed two small issues. The identified issues included data getting stored in the browser’s “session” storage and the display of the user ID in the location of...

Medical device manufacturers know the woes of getting your product through the FDA process and onto the market. Even for seasoned professionals, the regulatory process can sometimes be daunting or unclear. Although there are regulatory horror stories out there, it...

Users might get frustrated with software systems in the healthcare sector due to less compact UIs or functionality issues, such as taking a long time to load a web page. But what if the patient-sensitive data is exposed on a...

Almost after a year-long delay EUDAMED is finally here and has launched its first of its six modules in December 2020. Recently, the EU Commission posted a guidance document explaining how to manage the registration of legacy devices in the...

Medical Device Data Systems (MDDS) are hardware or software products that are intended to transfer, store, convert document forms and display medical device data. MDDS on its own does not modify the data or control any functions of the connected...