For medical device organizations preparing regulatory submissions, high-quality clinical evaluation plan & report writing has become a core compliance expectation. While historically associated with EU MDR submissions, the demand for structured clinical evidence is also increasing across U.S. regulatory pathways as the FDA continues shifting toward stronger evidence-based review standards and lifecycle documentation. Whether pursuing FDA market pathways such as a 510(k), De Novo, or PMA — or preparing a CE submission under EU MDR — robust clinical evaluation documentation is essential for demonstrating safety, performance, and alignment with intended use claims.