The Digital Health Consulting House

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EnGenius Services

EnGenius offers fixed fee packages and hourly services in the following areas:

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

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Our Non-BS* Manifesto

The EnGenius Difference

Proceduralism

Mandate

Duplication

Verbosity

Quality

Culture

Redundancy

Conciseness

Over

Over

Over

Over

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*Burdensome. See FDA Guidance titled “The Least Burdensome Provisions: Concept and Principles.”