Development of Medical Apps
Medical apps are more than just a receptacle for health data. They could be an integral part of patients’ treatments, helping them cope with their disease and increase treatment adherence. They can help doctors make a diagnosis and determine the treatment.
As medical software, medical apps may be subject to the Medical Device Directive (MDD) or the Medical Device Regulation (MDR); however, they don’t have to be. You should rely on an experienced partner to account for the several guidelines, laws and standards for the development of medical software.
Our certification to DIN EN ISO 13485 standard qualifies us to assist you in the development of medical apps and to act as the distributor.
Comprehensive services in detail
Together, we discuss whether your planned app should be approved as a medical device or the grounds for avoiding such classification. However, having the medical app declared a medical device could increase user trust and constitute a competitive advantage in the long term. Whatever you decide, we would be happy to help.
Requirements analysis
The issue of the requirements arises prior to software development: among other things, we analyze the prospective users and the places of use of the medical software. The problem that will be resolved lies at the core of the requirements analysis. This defines the software’s intended purpose.
Risk management in accordance with EN ISO 14971
The EN ISO 14971 standard specifies how the risk associated with a medical device can be identified and controlled for users. We conduct the necessary risk management activities throughout the entire life cycle of a medical device.
Software development in accordance with ICE 62304
Medical-devices manufacturers are obliged to comply with the legal requirements for their products’ usability. The usability file includes all documents that serve as evidence for usability. Naturally, we create this file in the course of the software development for you.
Clinical evaluation in accordance with MDD, ISO 14971
The Medical Device Directive (MDD) requires a clinical evaluation of medical devices, which is usually based on clinical data. We can provide you with sound support here too.
Usability file/usability in accordance with ICE 62366
Medical-devices manufacturers are obliged to comply with the legal requirements for their products’ usability. The usability file includes all documents that serve as evidence for usability. Naturally, we create this file in the course of the software development for you.
Documentation and conformity assessment
All the above-mentioned service components are documented in detail and incorporated into the technical documentation. The technical documentation is the basis of the conformity assessment.
Quality management system in accordance with EN ISO 13485
The entire development process must occur within a quality management system. We have the quality management system required for the development of medical devices, certified by TÜV Hessen (Technical Control Association in the State of Hesse) as the notified body. This entitles us to design and develop medical software and medical apps as defined by the Medical Device Directive.
Hosting and operation
Health applications are particularly demanding in terms of data security. By certifying our quality management system in accordance with EN ISO 13485, we are entitled to provide system support and hosting services for medical devices and medical apps. We ensure the legally compliant storage and processing of sensitive patient data. As an infrastructure as a service (IaaS) provider, we frequently take over all the data handling, operating from our ISO 27001 certified data center in Frankfurt or from a partner specializing in healthcare data.
We implement specialized security setups for sensitive data for operations in the USA in association with our hosting partner Armor, whose secure HIPAA-compliant and ISO 27001 certified cloud services we use as the basis for software operation.
Prof. Johner at the Johner Institute for Healthcare IT in Konstanz advises us on issues concerning the FDA approval of software as a medical device.