CE IIa marked digital remote monitoring medical device, in compliance with European regulation 2017/745 (MDR). Indicated for the remote monitoring of patients with chronic conditions.
MedicWise version 5.0 est certifiéeconforme au référentiel d'interopérabilitéet de sécurité des dispositifs médicauxnumériques.
Clinical evaluation by the HAS allows the management of remote monitoring of patients with chronic diseases under standard reimbursement.
Our software is developed according to the ISO 62304 standard, which guarantees safe and rigorous development processes for medical devices.
Complies with the requirements of the PGSSI-S (General Health Information Systems Security Policy) and the recommendations of the ANSSI.
An internal Data Protection Officer (DPO) ensures compliance with the GDPR and the protection of patients' health data.
The data is hosted in France by OVHcloud, certified provider HDS, guaranteeing a high level of security and data sovereignty.
Sêmeia is committed to an ISO 27001 and HDS certification process to guarantee the highest standards of information security.
Access to medical data is strictly reserved for authorized and trained users, guaranteeing a high level of confidentiality.
The infrastructures are operated by a certified outsourcer HDS, with strict separation between development and production environments.
Regular security audits and penetration testing are carried out by independent service providers to strengthen the resilience of our systems. The results are integrated into our continuous improvement process.
Ce canal de signalement vous permet de porter à notre connaissance tout fait illicite ou dangereux constaté au sein de l'entreprise Sêmeia, conformément au Dispositif de signalement. Nous garantissons une confidentialité complète tout au long du traitement du dossier. Seul le personnel habilité a accès à ces données au service de la santé connectée.
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