Klaris Information

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.