Compliance
Our accreditations and frameworks
Doctrin prioritizes information security and patient safety
Doctrin operates in healthcare with robust data protection standards. Information security is a priority at Doctrin. We are ISO/IEC 27001:2022 certified, which is an international standard that describes best practices for a management system for information security. This standard is designed to help organisations to secure information in a systematic and cost-efficient way.
By being ISO 27001 certified, we show our commitment to protecting our customers’ sensitive information.
OUR MEDICAL DEVICE
Doctrin Source
Doctrin’s platform provides a CE marked class 1 medical device under MDD 93/42/EEC, in accordance with the EU Medical Devices Directive. The device generates medical reports and recommendations based on the patient’s medical history.
In accordance with the transitional provisions, we have ongoing certification for our device under MDR with Intertek 2862 as a notified body.
The product does not perform auto-triage, diagnostics, or treatment.
All data is transferred encrypted, and processed in accordance with local laws and requirements and the EU General Data Protection Directive (GDPR).
Doctrin’s view on patient risk and how we work to improve it
Certifications
By possessing certifications, we guarantee adherence to industry-leading practices for software and risk analyses.
Risk management
We collaborate closely with clients in the domains of risk management and monitoring. Doctrin works according to ISO 14971, a standard governing the principles of risk analysis and risk management.
Evidence
We base our work on independent research and evaluate the ongoing performance and security of our device.
