Regulatory

Healthentia solution is certified and compliant with all required regulations for the use in Life Sciences and MedTech domains. 

Healthentia is a Medical Device Class I - ref. BE/CA01/1-72378

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

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

certifications Compliance
clinicalStudies

Life Sciences

Healthentia used as an ePRO should comply with the following

  • GxP compliance 
  • ISO 27001 certification & GDPR compliance 
  • 21 CFR Part 11 / 21 CFR 820 compliance 
  • HIPAA compliance 
MedicalTechnology

MedTech

Healthentia falls under the category Software as Medical Device (SaMD) 

Having an intended use to monitor remotely patients, it is required to follow the below certifications and compliances

  • Class I Medical Device (*) 
  • 21 CFR Part 11 / 21 CFR 820 compliance 
  • GxP compliance 
  • HIPAA compliance 
  • ISO13485 Certification  
  • ISO 27001 certification & GDPR compliance 

(*) ongoing Class IIa submission under MDR 

Healthentia market authorization  

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

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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.