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On March 26, Simbex joined healthcare, engineering, and business leaders at the University of New Hampshire for a digital health session hosted by the Center for Digital Health Innovation and the [...]

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FDA is releasing a draft guidance on the expanded use of remote regulatory assessments (RRAs) and how the FDA generally intends this tool, once finalized, to be incorporated consistently across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