About Exeges

In regulated manufacturing, every important question has the same answer: “it depends.” Does this change need a new 510(k)? Is this supplier still qualified? Is this complaint reportable?

“It depends” has a shelf life. In March, your change review board concludes that a firmware update to your infusion pump doesn’t require a new 510(k). That conclusion rests on maybe forty things: a paragraph in FDA’s guidance, a hazard in the risk management file, a requirement in the software specification, a verification report, a component spec, a claim on the labeling. In June, three of them change. In December, an FDA investigator sits down with your change control records and asks why the answer is still no.

Exeges keeps track of what the conclusion depends on. It watches those forty things, across the systems they live in. When one moves, it reads the change, flags whether the conclusion may be affected, and puts it in front of a human to decide.

Who it’s for

Exeges is for teams whose conclusions rest on evidence that keeps moving: spread across a dozen systems, changing after the signature, and still expected to survive an inspection. Regulatory affairs, quality systems, design assurance, supplier quality, CSV. Anywhere “if it isn’t documented, it didn’t happen” is the rule.

Interested? Get in touch.