EnGenius Solutions LLC

EnGenius Solutions is a consulting firm that helps digital health companies navigate the complex Quality Management System (QMS) requirements needed to legally sell medical software and devices, specializing in software-heavy medical devices including SaMD (Software as Medical Device), SiMD (Software in Medical Device), and AI/ML-enabled products. Their expertise bridges the gap between modern software development practices and medical device regulatory requirements, helping companies optimize on the typical spectrum of moving fast or staying compliant. EnGenius has enabled clients to release product updates quickly— even weekly through Agile lifecycles - all while maintaining all required safety standards and FDA compliance.

• Employees1
• Founded2023