Certifications and compliance.
CE-marked Class IIa medical device software with ISO 13485, GDPR and EU-regulatory documentation.
CE Class IIa · ISO 13485 · GDPR
CE-marked Class IIa medical device software with ISO 13485, GDPR and EU-regulatory documentation.
Cardiolyse is not a research prototype. It is a documented medical device operating under EU Regulations, with an ISO 13485 quality management system and ISO 27001-aligned information-security controls.
Cardiolyse is CE-marked as Class IIa medical device software under EU Regulations. Technical file and clinical evaluation available under NDA.
Certified quality management system for medical devices and full GDPR compliance for the processing of health data across the EU.
Certified by NHS Digital for Data Security and Protection compliance, meeting the standards required to handle patient data within the UK National Health Service.
Procurement and regulatory teams need the boundary stated plainly, so here it is. A certificate covers a defined intended purpose, not everything a platform can do.
Our controls follow ISO 27001 principles.
Most of this is available under NDA. Tell us who is reviewing and what they need to sign off, and we will send the relevant set rather than a generic pack.
Yes. Cardiolyse is CE-marked as Class IIa medical device software under EU Regulations and operates under an ISO 13485 quality management system. Data handling is GDPR-compliant with EU-hosted infrastructure and ISO 27001-aligned controls, and Cardiolyse is certified by NHS Digital for Data Security and Protection compliance.
Under NDA we can provide the declaration of conformity, intended-purpose statement, clinical evaluation summary, ISO 13485 certificate, security and data-protection documentation, and the DPA we would sign with you.
Yes. Alongside the hosted EU deployment, the analytics engine can be deployed into your own cloud tenancy or an isolated environment where data residency or network policy requires it. These deployments are scoped with your IT and compliance teams.
No. The certified intended purpose is to support a qualified healthcare professional. Findings are presented for review, and clinician sign-off remains part of the workflow for diagnostic use.
Write to info@cardiolyse.com and describe the review you are running. Our team will get back to you, and it helps if you tell us up front which documents your reviewer needs.The call topic, the project concept and the role you see for ECG. We reply with a proposed work package.
Tell us which standards your team is assessing against and who is signing off. We will send the relevant documents under NDA.
