Security and trust in digital medicine
Digitalisation in medicine and the associated establishment of digital health applications are advancing steadily. Quality, evaluation and regulation are the essential accompaniments of this development in order to establish security and the necessary trust in the health care system. QuR.digital advises and supports legally compliant and sustainable product development with standardized and agile methods as well as process support. From the idea to legal reimbursement, QuR.digital ensures that every digital application in medicine is marketable and complies with the regulatory procedures.
What we are offering.
> Certification support for digital health applications (diGA) up to the medical device (risk class I)
> Certification support for digital health applications (diGA) up to the medical device (risk classes IIa)
> Certification support for the acquisition of the BiM seal "Quality products Internet medicine"
> Certification support for digital health applications (diGA) towards a prevention product according to § 20 SGB V
> Accompaniment of process development and certification of harmlessness within the scope of all data protection requirements according to the GDPR.
> Examination and optimisation of all relevant data processing steps, documentation, security requirements, roles and risk processes.
> Development and monitoring of data protection concepts with reference to health data.
> Entwicklung von Evaluationskonzepten zwecks Nachweis eines positiven Versorgungseffektes im Hinblick auf die Herstellung der Erstattungsfähigkeit der digitalen Gesundheitsanwendung (diGA).
> Ensuring high quality standards by involving well-known partners in the field of academic performance and health services research.
> Support in price negotiations with all key players in the healthcare industry.