Medical Device QMS Consulting
SaMD/AIMD/MLMD Specialty
EnGenius Services
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
Our Non-BS* Manifesto
The EnGenius Difference
Proceduralism
Mandate
Duplication
Verbosity
Quality
Culture
Redundancy
Conciseness
Over
Over
Over
Over
*Burdensome. See FDA Guidance titled “The Least Burdensome Provisions: Concept and Principles.”