EnGenius Solutions – Medical Device Software (SiMD, SaMD, AIMD, MLMD) Quality Management System Consulting

EnGenius Solutions is a boutique consulting firm that offers Quality Management Systems consulting. EnGenius Solutions is differentiated by its unique expertise on medical device software (SaMD, SiMD, AIMD, MLMD) as well as its commitment to effective and efficient quality systems as captured by its non-BS manifesto.

EnGenius Solutions offers the services mentioned below. You can book an appointment here.

Early Regulatory and Quality Strategy

  • Regulatory Pathway Analysis

  • Pre-Submission Strategy

  • Quality System Readiness

  • Fundraising & Investor Support

  • Gap Assessments & Risk Planning

QMS Support

  • QMS Development & Implementation

  • eQMS Selection & Administration

  • Internal Audits & Regulatory Compliance

  • Process Optimization & Efficiency

  • Training & Staff Development

  • Fractional Quality Lead or Staff Augmentation

AIMD/MLMD/SaMD Specialty

  • AI Enabled Tools or Products

  • AI/ML Regulatory Strategy

  • SaMD Lifecycle & Documentation

  • Algorithm Validation & Bias Mitigation

  • Cybersecurity & Risk Management

  • Real-World Performance Validation