Digital health applications (DiGA)
Apps on prescription: Digital health applications (DiGA) are medical devices of class I or IIa that are subject to approval – but with "fast track" as an additional process option for entry into the BfArM's directory of reimbursable applications. This means that the manufacturers and distributors of DiGA are subject to legal requirements (e.g. a defined development process), compliance with which is necessary for placing the applications on the market. As experts in standards-compliant software development for medical devices, we are your partner for medical apps and web applications as well as for all related tasks and specifications before, during and after market launch.
Our services for you
Consulting: We advise and support you regarding your DiGA business plan, questions on EU conformity and CE certification, DiGA approval requirements and processes, post market surveillance, usability engineering including accessibility, and the translation of your product ideas into software requirements (requirements engineering), as well as all questions regarding data protection and cyber security, taking into account the BSI (e.g. BSI TR-03161) and BfArM requirements (ISMS implementation, cyber security of your development processes and ultimately also of your DiGA).
Software development: We develop your standards-compliant app and web applications including all documentation required for approval as a medical device. We also take into account relevant requirements regarding cyber security and the implementation of interfaces for networking with other systems (HL7 interoperability standard FHIR, etc.).
Do you need support just on a specific issue? We also offer services for the following individual disciplines:
- Advice on the requirements of the EU Medical Devices Regulation (EU MDR 2017/745) for CE certification (e.g. proof of essential safety and performance requirements, compilation of technical documentation, etc.)
- Data protection and information security management systems (ISMS according to ISO 27001)
- Cyber security (according to BSI technical guidelines, dedicated cyber security risk-management process, preparation of certification according to BSI TR-03161)
- Risk management (ISO 14971)
- Quality management (ISO 13485)
- Interoperability (HL7, FHIR etc.)
- Data science (data analytics, artificial intelligence systems, etc.)
Is your product likely to be subject to a higher risk class and therefore not to be placed on the market as a DiGA, but as an important medical device? As software specialists for medical devices up to the highest risk class, we will of course also develop your medical application up to class III.
Have we aroused your interest?
Then contact us now. Our life science team is available by phone and e-mail for a first meeting.
These are the next steps:
- Our experts will take two hours for you free of charge, listen to you carefully, answer initial questions and outline preliminary approaches to solutions.
- Requirements workshop: In the course of a one- or two-day workshop, we jointly perform a detailed analysis of your requirements.
- Project start: Alongside our experts, our project managers initiate the development of your software together with you. Regular status updates are important to us so that all project stakeholders are always on the same page and have the same focus on the project. In the process, we implement agile methods such as Scrum.
In order to actually turn a fixed idea or a serious consideration into a project, an initial spark is often necessary that acts like a door opener.
This is precisely why we created our DiGA consultation hour, which took place a total of three times from March to July 2022.
The topics covered were:
- Efficient development of a DiGA: automated test and upload process (German video)
- Risk management and IT security at DiGA: procedure, experiences and tips from practice (German video)
- From business plan to finished DiGA (German video)
Does this sound interesting to you? Click in and feel free to ask us your questions about it now.