Klaris

Klaris is an AI-native regulatory compliance platform for medical device teams, providing automated review of technical documentation before regulatory submissions and audits. Founded by Francesco Corazza (10 years in medical device clearance) and Mihai Sorin Dobre (AI engineer, formerly at a company acquired by Bosch), Klaris acts as a second opinion that catches documentation gaps and potential non-conformities against regulations such as EU MDR, ISO 14971, IEC 62366, and CE Marking requirements. The platform is used by teams developing 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 with zero data retention.