Quality

Breaking news hit early this week regarding potential problems with Johnson & Johnson’s one-shot COVID vaccine, causing the FDA and the CDC to recommend pausing the administration of the vaccine until further investigation can be completed. On top of canceled...

Every year April 7th is celebrated around the world as World Health Day. Never has this day been more important than it is right now. As many are wishing for the day that life is back to normal or the...

Medical devices are made to save lives; but what happens if these devices cause more harm than good? There can be varying consequences, typically dependent upon the size of the organization. If there is a life-threatening or serious issue with...

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...

Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or...