About Ready... Set... Evidence
A platform built by someone who has lived the exact same pain you’re living right now.
The origin story
The creator of Ready Set Evidence has spent over a decade inside medical-device and SaaS companies — wearing every hat from clinical evaluation and post-market surveillance to regulatory submissions and quality management.
They repeatedly found themselves building increasingly sophisticated spreadsheets (and later entire Smartsheet ecosystems) just to keep up with the growing complexity of EU MDR requirements. At one point they were literally trying to force a novel single-cohort meta-analysis method into Smartsheet — and that was the moment of clarity:
“Why doesn’t a proper tool for this exist?”
Plenty of academic-grade literature review and meta-analysis platforms exist. But virtually nothing is built from the ground up for the very specific, regulator-driven questions we have to answer with real-world evidence — complaint data, vigilance reports, registry data, service records, and all the messy, non-standardised sources that come with them.
The pricing frustration that finally broke the camel’s back
Year after year, I watched the same cycle repeat across nearly every regulatory or clinical evidence software provider:
Opaque pricing → aggressive annual increases → new layers of “enterprise” features nobody asked for → bigger sales teams → sponsored golf outings → and all of it rolled into your invoice while your own device margins stayed flat or shrank.
Meanwhile, every QMS, every product category, every disease state has its own legitimate quirks — yet “customisation” is treated like a luxury upsell instead of table stakes.
Ready... Set... Evidence exists because someone finally decided to build the system we always wished existed — focused, transparent, fairly priced, and relentlessly oriented toward getting the actual regulatory work done instead of funding someone else’s marketing budget.
You won’t find glitz, glamour, or a 50-person sales team here. You will find a problem-solver who is obsessed with making clinical evaluation, PMS, and regulatory documentation faster, cheaper, and less painful — for good.