Labor recovered (65% doc management, 70% audit prep)
Based on time savings reported by Greenlight Guru customers and eQMS adoption benchmarks. Applied to team size, hourly rate, and weeks per year over your full runway.
Audit
remediation cost avoidance
Audit prep hours are the primary driver (45% weight), followed by document count (35%) and team size (20%). A probability-weighted expected value of remediation cost, conservatively capped at $200K. A single 483 observation costs $50K to $500K to remediate.
Months faster to submission
Base rate by submission type (510k: 1.5 months, De Novo: 2 months, PMA: 3 months, CE Mark: 1.5 months) scaled by runway years. A team 36 months out benefits from the eQMS for roughly 3x longer than a team 12 months out, and accumulates more time saved as a result.
Value of faster submission
Months saved multiplied by estimated monthly burn rate, which varies by submission complexity. Pre-market medtech companies typically burn $150K to $400K per month. Values used are conservative midpoints.
Document count range
Slider reflects a range from early-stage teams with a handful of SOPs up to mature pre-market companies with full design documentation, part specifications, and controlled records approaching 1,000 documents.