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FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across [...]

According to the most recent "U.S. Product Safety And Recall Index" report by Sedgwick, manufacturing defects are the leading cause for product recalls in 2023 through the month of March.

In medical device engineering, the pursuit of elegance in design goes far beyond surface aesthetics, embodying a philosophy that seamlessly blends form, function, and usability to create [...]

Read about AAMI and BSI partner is to publish guidance on artificial intelligence and reimbursement lags for prescription digital therapeutics.

Wearable motion sensors are everywhere, including in smart watches and fitness trackers. Because of this, it is now possible to design wrist-worn products that detect when a person falls and [...]

Read about the FDA-issued Marketing Submission Recommendations and the new rules the EPA has proposed for medical device sterilization.

In the world of data management, maintaining clean and accurate databases is key to the success of any organization.

There are some tools that punch above their weight, and with some beautiful math, can produce powerful insights into incredibly complex and large datasets. One of these elegant tools that we use [...]

In our last article, we discussed how Simbex’s approach to diagnosing and resolving performance issues throughout the medical device development process, using design techniques such as building [...]

The word diagnosis is made of up of two Greek roots meaning “to know throughout” or to “understand completely”.  We usually think of diagnosis in the context of illness, but it applies to problem [...]