Company profile

Klaris

EU MDR Technical Documentation review and remediation for MedTech manufacturers

Industry
Medical Equipment Manufacturing
Employees
6
Headquarters
London
Founded
2024
Office locations
1

Klaris company summary

Klaris is a company in the Medical Equipment Manufacturing industry, headquartered in London, founded in 2024. On LinkedIn the company has around 6 employees. Its listed specialties include Medical Device Compliance, Regulatory Intelligence, CE Marking, EU MDR 2017/745, ISO 14971:2019.

What technology does Klaris use?

No technologies detected yet. Warmrank rechecks company websites on a rolling basis.

About Klaris

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.

Specialties

Medical Device ComplianceRegulatory IntelligenceCE MarkingEU MDR 2017/745ISO 14971:2019IEC 62366-1:2015ISO 10993-1:2025

Where is Klaris located?

Klaris lists 1 location.

London, E1 6HU, GBHQ
186 Shoreditch High Street

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Frequently asked questions about Klaris

What does Klaris do?

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.

How many employees does Klaris have?

Klaris has around 6 employees on LinkedIn.

Where is Klaris headquartered?

Klaris is headquartered in London.

When was Klaris founded?

Klaris was founded in 2024.

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