Klaris is a startup building AI-driven solutions to address regulatory and compliance bottlenecks in the medical device (medtech) industry.
Frequently Asked Questions
Where is Klaris located?
Klaris is located in London, United Kingdom.
What industries does Klaris operate in?
Klaris operates in the following industries: medtech, regulatory-compliance, healthcare, artificial-intelligence.
What is Klaris?
Klaris is an AI-powered regulatory compliance platform designed specifically for the MedTech industry to streamline complex processes such as EU MDR and FDA 510(k) submissions.
How does Klaris assist MedTech companies with documentation gap analysis?
The platform uses agentic reasoning to map technical documentation against applicable regulatory requirements, identifying missing evidence or non-conformities in minutes rather than days.
Does Klaris provide remediation guidance for non-conformities?
Yes, every finding identified during the analysis includes specific remediation guidance to help R&D and regulatory teams address gaps before submitting to authorities or undergoing an audit.
How does Klaris ensure the security of proprietary intellectual property?
The platform is ISO 27001 certified and GDPR compliant, employing end-to-end encryption and a strict zero-data-retention policy with LLM providers to ensure proprietary data never trains AI models.
Can Klaris help monitor compliance when regulations change?
The system allows users to re-run gap analysis whenever new ISO or MDCG guidance is updated, instantly showing which documents require revisions to maintain compliance.
Is Klaris compliant with the EU AI Act?
Klaris operates as a low-risk AI system deployer and is fully compliant with the regulatory framework established by the EU AI Act.