News

From reimbursement challenges, regulatory clarity for low-risk devices, to the rise of AI in home health, here is our perspective on the recent FDA call for comments! simbex-blog-pdf

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across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

FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently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

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

Last Month, I traveled to the NIH headquarters in Bethesda, MD for the semi-annual meeting of the External Collaborative Panel (ECP) for the Limb Loss and Preservation Registry (LLPR). For the [...]

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 [...]