Regulatory Complete Rewrite of ISO 10993-1 Creates Industry Buzz The proposed draft for the next revision of ISO 10993-1 represents a complete overhaul. The draft also takes a strong position on [...]
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FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across [...]
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 [...]
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