EnGenius Solutions LLC

medical devices

About

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.

Technologies

NSOne Gmail Google Apps Microsoft Office 365 Mobile Friendly Typekit Squarespace ECommerce

Keywords

iso 623042006a12015 simd samd medical device quality management system 21 cfr 820 21 cfr part 11 software development lifecycle ai eu mdr eu mdd iso 134852016 medical equipment manufacturing medical devices hospital & health care

Location

555 Anton Blvd, Costa Mesa, California, United States, 92626-7010

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