Réglementaire

La solution Healthentia est certifiée et conforme à toutes les réglementations requises pour une utilisation dans les domaines des sciences de la vie et des technologies médicales.

Healthentia est un dispositif médical Class I - ref. BE/CA01/1-72378

Read more about medical modules and device functionalities that are covered under the CE mark.

En savoir plus sur les modules médicaux et les fonctionnalités des appareils couverts par le marquage CE.

certifications Compliance
clinicalStudies

Sciences de la vie

Healthentia utilisé comme ePRO doit être conforme aux exigences suivantes

  • Conformité GxP
  • Certification ISO 27001 et conformité RGPD
  • Conformité à la partie 11 du CFR 21 et à la norme 820 du CFR 21
  • Conformité HIPAA
MedicalTechnology

Technologie médicale

Healthentia fait partie de la catégorie Logiciel en tant que dispositif médical (SaMD)

Ayant pour objectif de surveiller les patients à distance, il est nécessaire de suivre les certifications et conformités ci-dessous

  • Class I Medical Device (*)
  • Conformité à la partie 11 du CFR 21 et à la norme 820 du CFR 21
  • Conformité GxP
  • Conformité HIPAA
  • ISO13485 Certification
  • Certification ISO 27001 et conformité RGPD

(*) ongoing de Class IIa en cours dans le cadre du MDR

Autorisation de mise sur le marché de Healthentia

Europe:

Product registration CE mark / Class I
Expiration 25-05-24
MD Regulation MDD 93/42/EEC
Vigilance Notification Period • Serious threat to public health:
immediately <2 calendar days
• Death or unanticipated serious deterioration in a person's state of health:
immediately < 10 calendar days
• Other serious incident:
immediately < 15 calendar days
Basic UDI-DI 54199801789HLTv3GW (Healthentia v3)

United States:

FDA510(k) application to be submitted in 2022

Made for your Business

Have any question? Visit the contact page to reach out to us.

Healthentia medical device is a smartphone app for chronic disease patients and a clinical dashboard for healthcare professionals. Healthentia is offering advanced RPM features through its medical modules that empower patients with chronic diseases and contribute to better health outcomes. Its intended purpose includes the collection of physiological data, visualization and trend analysis, transmission of patient outcomes to healthcare providers, and the enabling of personalized interactions through a virtual coach. Further to the RPM features, Healthentia is addressing the root cause of chronic disease, the behavioral risk factors and through personalized virtual coaching, assists patients towards a lifestyle change.

Healthentia is also used for Decentralized Clinical Trials (DCT, leveraging best-of-breed of eClinical studies features, such as eRecruitment, eConsent, teleconsultation/ televisit, ePRO-IoT integration, and virtual coaching. Healthentia empowers patients and gives them an active role in taking trial’s actions, rather than bringing them to the trial sites; thus facilitating clinical trial optimization, accelerating trial processes, reducing drop-out and failure rates, and validating drug/intervention efficacy and effectiveness with Real World Data insights. Healthentia is used by Top5 Pharma and large hospitals and operates under the strict regulatory framework of Good Clinical Practice.