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Dawn Health A/S
Sundkaj 153, 1st floor on the right
Nordhavn
2150
Denmark

Certificate number: MD 713595
Scope: Manufacture, design, development, sales, installation and servicing of Clinical Management Support Software.

Standard/Scheme number or name	Start Date	Expiry Date
ISO 13485: 2016	2020-02-03	2027-01-25

Certificate number: MDSAP 788529
Scope: Manufacture, design, development, installation and servicing of Clinical Management Support Software and Self-care Monitoring/Reporting Software.

Standard/Scheme number or name	Start Date	Expiry Date
MDSAP	2024-01-26	2027-01-25

Certificate number: IS 788689
Scope: The Information Security Management System supporting the design, development and maintenance of Health Software Products.

Standard/Scheme number or name	Start Date	Expiry Date
ISO/IEC 27001:2022	2024-01-22	2027-01-21

Certificate number: HDS 810047
Scope: The Dawn Health ISMS governs services used for the processing of personal health data in digital activities in conformance with activities 3, 4 and 5 of the French reference system HDS:2024 and internal operations related to design, development and maintenance of health software products as per the ISO 27001:2022 certified ISMS and the Statement of Applicability version 9 dated July 28th 2025. The scope cover the 3 levels of HDS:2024: - The provision and maintenance in operational condition of the virtual infrastructure of the information system used to process the health data; - The provision and maintenance in operational condition of the platform for hosting information system applications; - The management and operation of the information system containing the health data. The organization is certified according to ISO 27001:2022. The organization is certified according to ISO 27001:2022. This HDS Certificate is valid subject to a valid ISO 27001 certification for the same scope.
Le SMSI de Dawn Health régit les services utilisés pour le traitement des données de santé à caractère personnelles dans les activités numériques conformément aux activités 3, 4 et 5 du référentiel français HDS:2024 et les opérations internes liées à la conception, au développement et à la maintenance des produits logiciels de santé selon le SMSI certifié ISO 27001:2022 et la Déclaration d'Applicabilité version 9 du 28 juillet 2025. Le périmètre couvre les 3 niveaux du HDS:2024 : - La mise à disposition et le maintien en condition opérationnelle de l'infrastructure virtuelle du système d'information utilisée pour traiter les données de santé ; - La mise à disposition et le maintien en condition opérationnelle de la plateforme d'hébergement des applications du système d'information ; - La gestion et l'exploitation du système d'information contenant les données de santé. L'organisation est certifiée ISO 27001: 2022. L'organisation est certifiée selon la norme ISO 27001:2022. Ce certificat HDS est valable sous condition d’une certification ISO 27001 valide pour le même périmètre.

Standard/Scheme number or name	Start Date	Expiry Date
HDS:2024	2025-01-08	2028-01-07