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Certificate number:
MD 800345
Scope: Design and development, production, distribution and maintenance of standalone software as medical devices intended to support doctors in helping diagnosing, preventing, monitoring, predicting, prognosing, treating, alleviating disease and decision-making for drug treatment.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
ISO 13485: 2016 | 2025-04-03 | 2028-04-02 |
Certificate number:
AIMS 817029
Scope: Development and provision of AI systems, based on retrieval augmented generation and large language models, for medical knowledge access and decision-making support process in healthcare sector. Use of third-party large language models for organisational operations. Statement of Applicability Ver 0.1 dated 28/04/2024.
Standard/Scheme number or name | Start Date | Expiry Date |
---|---|---|
ISO 42001:2023 | 2025-06-19 | 2028-06-18 |