Klaris

Klaris reviews Technical Documentation for medical device manufacturers, finding gaps and suggesting fixes before reviewers do.Weeks of expert work are compressed into one overnight pass.Why Klaris works:- Every requirement in our library was authored and validated by senior experts: former Notified Body reviewers, senior consultants, and manufacturer-side regulatory leaders. The AI matches your evidence to a clause definition a human signed off on.- Every gap cites the clause, the page, and a drafted fix. Deterministic by architecture: same file in, same findings out.- Secure: ISO 27001:2022 certified. GDPR compliant. EU-hosted. Zero data retention.Coverage: EU MDR 2017/745, its guidance documents, and applicable ISO standards. Class I-III, from complex implantable devices to SaMD.