Krystal Santiago

About Krystal Santiago

I help medical device innovators get breakthrough technologies into human use faster safely.After 20+ years navigating FDA submissions and pioneering early feasibility studies, I\'ve mastered the art of regulatory strategy that actually accelerates innovation. No bureaucratic roadblocks. No analysis paralysis. Just clear paths to first-in-human trials.My sweet spot: Early-stage regulatory strategy & clinical planningFDA Early Feasibility Studies (EFS) and actually working with the FDABreakthrough Device Designation strategy and executionPre-Submission meetings that actually get you answersClinical protocol design that satisfies FDA while keeping costs manageableWhat sets me apart:I\'ve been in your shoes - led regulatory at startups and big companies alikeDirect FDA negotiation experience - I know what reviewers actually care aboutPragmatic approach - I build strategies you can execute with limited resourcesI specialize in working with:Pre-revenue startups planning their regulatory pathwayCompanies with novel devices that don\'t fit traditional classificationsTeams preparing for first-in-human studiesInnovators seeking Breakthrough Device DesignationMy philosophy: The best regulatory strategy is invisible - it clears the path for innovation rather than creating hoops to jump through.

Experience

1. Pathway Leader

   Mind Grove

   Jun 2025 — Present

Education

• California State University-Long Beach

  MS, Applied Statistics

• California Polytechnic State University-San Luis Obispo

  BS, Industrial Engineering

Skills

• Quality Management
• Iso
• Fda
• Iso 13485
• Design Control
• Medical Devices
• Capa
• Fda Gmp
• Medical Device Directive
• Supplier Quality
• Iso 14971
• Fda Early Feasibilty Program
• Quality System
• Quality Control
• Fda Early Feasibilty Program
• Quality Auditing
• Quality Assurance
• Regulatory Submissions
• Cqe
• Sterilization
• Statistics
• Root Cause Analysis