Based in Costa Mesa, California, EnGenius Solutions helps medical software and digital health companies streamline their path to regulatory compliance and product quality. Their service offerings span early-stage regulatory and quality strategy (regulatory pathway analysis, pre-submission guidance, fundraising support, gap assessments), through full Quality Management System (QMS) support including eQMS selection, implementation, audits, process optimization, and training. They have particular expertise in AI/ML-enabled devices: lifecycle documentation, algorithm validation, bias mitigation, cybersecurity, and real-world performance validation. EnGenius positions itself as “The Digital Health Consulting House,” emphasizing reducing regulatory and quality burden while maintaining high standards helping clients move fast without sacrificing safety, compliance, or effectiveness.