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MDR, DiGAV, BSI TR-03161 and data protection test criteria for DiGAs

DiGA product development in 3 months

Digital health start-ups face high financing hurdles to meet the technical and regulatory requirements for their DiGA (digital health application). And they are currently facing new additional costs for the following necessary proofs:

  • BSI certificate data security according to BSI TR-03161 required from 01.01.2025
  • Data protection certificate in accordance with the data protection test criteria for DiGAs and DiPAs (BfArM)

Investor-friendly DiGA production

With the mHealth Suite platform, you can achieve cost security and fast time-to-market for your DiGA app. During product development with the mHealth Suite, conformity with MDR, DiGAV, the “Test criteria for data protection for DiGAs and DiPAs” (BfArM) and data security in accordance with BSI TR-03161 is always included.

The modular and indication-agnostic software technology of the mHealth Suite platform realizes your individual product for your medical content and therapy logic – DiGA-ready in 8 weeks.

Our solution for DiGA manufacturers

The mHealth Suite reduces costs and accelerates time-to-market

✔ Data protection and
Data security

DiGA products by mHealth Suite fulfill the requirements for proof of data protection according to the test criteria of the BfArM (Federal Institute for Drugs and Medical Devices) – as well as for data security according to the Technical Guideline TR-03161 of the BSI (Federal Institute for Information Security).

✔ Conformity
MDR and DIGAV

A DiGA product by mHealth Suite meets the requirements of the MDR and DiGAV at all times. It is therefore also possible to launch the product as a lifestyle product – with certification as a medical device and application for DiGA approval at a later date, without any new development. Boost your business case with mHealth Suite Products, flexible, scalable, fast

✔ Carefree package

These services are regularly included in the license price of the mHealth Suite

  • Development
  • Maintenance costs for apps
  • Maintenance costs for servers
  • Hosting for servers
  • Operation of servers
  • Third-level support
  • Technical assistance with second-level support
  • Further development (limited): Your content adaptations, optimized approach to patients, possibly supplementary exercises, up to improvement of therapy concept
  • Achievement, monitoring of conformity plus any necessary adjustments*:
    • Medical Device Regulation (MDR)
    • Digital Health Applications Ordinance (DiGAV)
    • BSI TR-03161 – Technical Guideline Cybersecurity
    • Data protection test criteria for DiGAs and DiPAs (BfArM) including establishment of GDPR processes with the help of ready-made templates

* excl. certain manufacturer obligations that we as a supplier cannot/may not assume

Get a picture now

Plan B - for your project too?

What is conceivable is now also feasible

Next level for your app product: be DiGA-ready
in around 8 weeks

Always on the safe side

"My DiGA product by mHealth Suite is sustainably compliant with regulations"

  • Digital therapy
  • Digital therapy support

*** Trade fair highlight of the DMEA 2024 ***

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