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FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently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