Klaris is an AI‑driven platform that automatically analyses medical device technical documentation against the full EU MDR 2017/745 requirements, mapping each file to the relevant clauses and highlighting missing or inconsistent content. It provides traceable findings, remediation guidance, and ongoing consistency checks while ensuring data security with ISO/IEC 27001:2022 certification and GDPR‑compliant processing in the EU/UK.
Funding
$152.3K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Medical device manufacturers must produce extensive technical documentation to meet EU MDR 2017/745 requirements, but identifying missing or inconsistent information across many documents is time‑consuming and error‑prone. Gaps or drift in documentation can lead to non‑conformity, audit failures, and delayed market entry.
Solution
Klaris provides an AI‑driven platform that automatically analyses uploaded technical documentation against the full set of EU MDR requirements. The system maps each document to the relevant clauses, annexes, and references, highlighting any missing or inconsistent content with clear reasoning. Users can trace every finding back to the source evidence and receive remediation guidance to close gaps before submission, PRRC sign‑off, or audit. The platform also monitors document consistency over time, flagging drift when definitions change and showing all impacted files. All processing is performed within EU/UK regions under ISO/IEC 27001:2022‑certified security and GDPR compliance, ensuring data privacy and protection.
Target Audience
Primary customers are regulatory affairs and compliance teams within medical device manufacturers developing products subject to EU MDR 2017/745.
Features
- Automated gap analysis that checks documentation against hundreds of expert‑validated EU MDR requirements filtered by device characteristics
- Direct linking of each finding to the specific clause, annex, or reference and to the supporting evidence in the uploaded files
- Remediation recommendations with prioritisation to help teams address the most critical gaps before deadlines
- Consistency checking that highlights deviations across documents when definitions are updated, preventing drift and non‑conformities
- Side‑by‑side document comparison with highlighted differences and clear reasoning for each change
- Secure, encrypted data handling (TLS 1.3 in transit, AES‑256 at rest) and ISO/IEC 27001:2022 certification, with GDPR‑compliant processing in EU/UK regions