Regelgevend
De Healthentia-oplossing is gecertificeerd en voldoet aan alle vereiste voorschriften voor gebruik in de Life Sciences- en MedTech-domeinen.
Healthentia is een medisch hulpmiddel Class I - ref. BE/CA01/1-72378

Lees meer over medische modules en apparaatfunctionaliteiten die onder de CE-markering vallen.


Levenswetenschappen
Healthentia dat als ePRO wordt gebruikt, moet voldoen aan de volgende voorwaarden
- GxP-naleving
- ISO 27001-certificering en AVG-naleving
- 21 CFR Part 11 / 21 CFR 820-naleving
- HIPAA-naleving

MedTech
Healthentia valt onder de categorie Software als Medisch Hulpmiddel (SaMD)
Omdat het apparaat bedoeld is om patiënten op afstand te monitoren, is het vereist om de onderstaande certificeringen en nalevingen te volgen
- Class I medisch hulpmiddel (*)
- 21 CFR Part 11 / 21 CFR 820 naleving
- GxP-naleving
- HIPAA-naleving
- ISO13485 certificering
- ISO 27001-certificering en AVG-naleving
*) lopende Class IIa indiening onder MDR
Marktvergunning Healthentia
Europa:
Product registration | CE mark / Class I |
Vervaldatum | 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
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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.