We didn't start in MedTech.
That's exactly why we saw what everyone inside it had stopped noticing.
Right now, somewhere in a medical device company, a quality team is copy-pasting complaint data into a spreadsheet. A regulatory affairs manager is manually assembling an MDR report that should have been submitted three days ago. The director of post-market surveillance is explaining to leadership again why the PSUR took six weeks to generate.
These are not bad teams. These are exceptional people doing critical work with tools that were never built for it.
2.6 million MDRs were reported to the FDA last year. The teams responsible for filing them are not growing.
Post-market surveillance is not a back-office function. It is the mechanism by which the medical device industry keeps patients safe, regulators informed, and products on the market. It is mandatory, consequential, and growing in complexity every year.
EU MDR enforcement is tightening. Global regulatory requirements are multiplying. Complaint volumes are rising. And the industry is still managing it with generic quality management systems that were designed for document control, not for complaint intake, adverse event detection, regulatory reporting, or recall management.
The VP of Quality, who managed 50 complaints a month in 2019, is now managing 500. The Regulatory Affairs director who filed MDRs for one market is now filing for twelve. Headcount didn't triple. Budgets didn't triple. The workload did.
That is the problem Smarteeva was built to solve.
Not as a module inside a quality management system. Not as a bolt-on to a platform that was designed for something else. As a purpose-built post-market surveillance platform from complaint intake to MDR submission, recall management to PSUR generation, engineered specifically for the regulatory realities that medical device companies face every day.
One platform. Same depth for a 10-person startup as a 10,000-person enterprise. No tiers. No feature gates.
We started with a compliance product and a belief that the tools should be as good as the people using them, regardless of the size of the company those people work for. That belief hasn't changed. The tools just got a lot better.
