Grant Gimby

About Grant Gimby

I help Medical Technology and SaMD companies navigate the high-stakes intersection of rapid innovation and global regulatory compliance. With 20+ years of experience—ranging from Class implantables to AI-driven diagnostics—I specialize in transforming complex regulatory roadmaps into modular, commercial-first strategies.The Result? Reduced regulatory submission costs by an average of 40% and accelerated time-to-market by 9 months.Whether leading $8.5M+ operational budgets at enterprise scale (Walgreens, Edwards Lifesciences) or providing fractional leadership for high-growth startups via Red Peak Technology Group, my focus remains the same: de-risking the product lifecycle while driving measurable ROI.Core Expertise- Regulatory Strategy: 510(k), De Novo, Q-Sub, and PMA navigation- Quality Engineering: ISO 13485, 14971, and IEC 62304 compliance- Digital Transformation: AI/ML validation, SRE, and GxP cloud migration- Operational Excellence: Lean Six Sigma, M&A integration, and fractional C-suite advisory.Let’s build a quality ecosystem that acts as a competitive advantage, not a bottleneck.

Experience

1. Founder Fractional VP of Regulatory & Quality Engineering

   Red Peak Technology Group

   Apr 2024 — Present

   I lead Red Peak Technology Group to provide high-altitude fractional leadership for MedTech, SaMD, and Avionics firms. I specialize in turning complex regulatory requirements into modular commercial strategies that de-risk the product lifecycle and accelerate time-to-market.Strategic Impact- Commercial Acceleration: Architected modular 510(k) and De Novo roadmaps that reduced initial regulatory costs by 40% and accelerated market entry by 9 months- Regulatory Architecture: Engineered \"Split-Predicate\" strategies for Neuro-monitoring and Wearable platforms, successfully redefining \"Home Use\" vs.\"Clinical\" indications to streamline FDA clearance- Innovation in Compliance: Deployed proprietary, custom-trained Regulatory AI systems to automate gap analysis, reducing manual documentation cycles by 50%- Advanced V&V: Designed high-fidelity shielded test fixtures for signal-to-noise ratio (SNR) validation per IEC 60••••26 and mentored cross-functional engineering teams (>70+ personnel) in IEC 62304.Core Focus Areas- Fractional Executive Leadership: Providing P&L-focused advisory for Quality and Regulatory programs- SaMD & AI/ML Validation: Establishing GAMP 5 and 21 CFR Part 11 frameworks for software-driven diagnostics and automated systems- Global QMS Governance: Scaling ISO 13485, MDSAP, and EU MDR/IVDR compliant systems for startups and mid-market organizations- Human Factors (HE75): Authoring Use-Related Risk Analyses (URRA) and summative validation for complex patient-safety environments.I partner with boards and executive teams to ensure that quality systems act as a competitive advantage—not a bottleneck.

Education

• DeVry University

  Bachelor’s Degree, B.S. Technical Management, emphasis in Operations Management and Electronics Engineering

• Keller Graduate School of Management of DeVry University

  Master’s Degree, M.S. Information Systems Management, emphasis in Medical Information Systems

• University of Sedona

  Doctor of Philosophy - PhD, Business Ethics, emphasis in Artificial Intelligence in Biomedical Technology

Skills

• R&D
• Maintenance & Repair
• Product Development
• Systems Engineering
• Systems Design
• Windows System Administration
• Systems Integration
• Design Control
• Linux Systems
• Product Life Cycle
• Biotechnology
• Iec
• Sound
• Cancer Research
• Cloud Storage
• Iso
• Business Process Improvement
• Fda
• Concept Development
• Lean Six Sigma
• Metrology
• Cad Tools
• Process Improvement
• Microsoft Office
• Cross-Functional Team Leadership
• Hardware Diagnostics
• Project Management
• Calibration
• Video
• Healthcare
• Medical Devices
• Medical Diagnostics
• Leadership
• Biomedical Engineering
• Software Testing
• Cloud Applications
• Troubleshooting
• Testing
• Electronics
• Stakeholder Management