Medical devices are designed to help people. They can, however, only fulfil this purpose when their software has been developed from the ground up to be safe and secure. We use a holistic approach to ensure that risks are identified early and that suitable control measures are implemented to reduce them appropriately. Using state-of-the-art software engineering enables developers to release new features regularly while ensuring the level of quality required by such strict regulatory requirements as the provisions of the EU’s Medical Device Regulation (MDR) or the legal stipulations of the FDA.
Development of medical software & apps
We develop high-quality, innovative medical device software – from embedded to desktop and cloud applications. We’ll support you throughout the entire product lifecycle, from the requirements analysis to the design and implementation of the solution – right through to the launch and beyond.
UI/UX
The medical device software we develop for our clients does more than merely fulfil regulatory requirements. It also provides an intuitive interface and minimises the risk of operating errors.
Development processes
We’ll work with you to establish a lightweight product development process which suits your company, supports your developers in their daily duties, and is carried out in accordance with agile principles – all while fulfilling regulatory requirements.
Embedded Medical Software
Our innovative software solutions integrate seamlessly into medical devices, improve patient safety and optimize clinical processes.
Medical Apps
Our specialized apps integrate advanced technology to provide physicians and patients alike with user-friendly and effective health monitoring.
Cyber Security for Medical Devices
Our customized security solutions ensure the reliability and protection of your networked medical devices to secure sensitive patient data and guarantee the integrity of your systems.
For the ARCUS clinics and practices, inovex has created a new digital patient portal that not only enables patients to book appointments digitally, but also makes all information about their treatment plan accessible. At the same time, administration was made easier for the clinic staff.
We interviewed Ralf Lehnert, Head of IT at ARCUS Hospitals and Medical Practices, and Meliha Müller, Scrum Master & Product Discovery Coach at inovex, about their joint projects.
In der aktuellen Zusammenarbeit zwischen inovex und den ARCUS Kliniken wurde die Bettenplanung mithilfe mathematischer Modellierung optimiert. Das System ermöglicht eine vollautomatisierte und intelligente Bettenbelegung unter Berücksichtigung relevanter Parameter.
IEC 62304 defines the requirements of the software development lifecycle. In terms of the basic structure, it resembles the traditional V-model, but no specific process model is explicitly defined. In addition to the actual software development process, the standard also defines accompanying processes – including, for example, risk management in accordance with ISO 14971 and configuration management.
ISO 14971 stipulates how risk management for medical products should be applied and ensured throughout the product’s entire lifespan. We strongly recommend incorporating risk management at a very early stage in the product development process to allow effective risk control measures to be implemented.
Traditional usability engineering ensures that products fulfil their purpose to the maximum possible extent – while remaining enjoyable to use. Standard IEC 62366 goes beyond this requirement in ensuring, for example, that operating errors are avoided.
Frequently asked questions about medical device software
When is a device a medical device?
A device is classified as a medical device if it is intended to fulfill a medical purpose in humans. It can or should therefore be used for diagnostic or therapeutic purposes in connection with diseases or other health conditions.
In the European Union, the requirements and definitions for medical devices are set out in Regulation (EU) 2017/745 on medical devices (MDR). A detailed definition and explanation can be found on the Website of the Bundesgesundheitsministeriums.
Can software be a medical device?
Yes, there are several definitions and types of software used for medical purposes. Software as a medical device describes standalone software that fulfills medical purposes, such as diagnostics.
Medical device software is somewhat broader according to the EU definition. It can be both standalone software and part of a medical device, e.g. in the form of embedded software or as control software.
Which healthcare software does NOT count as a medical device?
Not all software that is used as a solution in the healthcare sector is a medical device. Most wellness and fitness software does not fall into this category. Hospital information systems (HIS) are also exempt.
Although HIS are not subject to the same criteria as medical device software, they must also meet strict quality requirements to ensure the safe handling of patient data.
