Klaris helps medical device teams review regulatory documentation before submissions and audits.

Founded and backed by medical device veterans, we built the tool we wished existed: a second opinion that catches gaps before reviewers and auditors do.

We review technical documentation against regulations flagging potential non-conformities with clear reasoning and traceability.

Used by teams across Class I-III devices, from startups pursuing first CE mark to companies managing legacy portfolios through MDR transition.

🔒 ISO 27001:2022 certified. GDPR compliant. EU-hosted. Zero data retention.

📫 hello@klaris.ai | www.klaris.ai

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