State-of-the-Art (SOTA) in MDR 2017/745
A Whitepaper on Best Practices and Compliance Executive SummaryState-of-the-Art (SOTA) is a cornerstone concept within the EU Medical Device Regulation (MDR) 2017/745. Although the regulation does not define the term explicitly, it is referenced extensively in guidance documents and regulatory assessments. SOTA serves as the benchmark for technological, clinical, and risk management expectations in the […]