Digital support for patients with cardiovascular disease.
Summary
CardioCare
This is exactly where CardioCare comes in, the digital platform of our US client Recardio Inc. from San Francisco. The app is recommended to the patient by their treating physician and then guides them independently through everyday life with their condition. It conveys structured knowledge about the patient’s own condition, about lifestyle, medication and medical treatment. An integrated medication management feature reliably reminds patients to take their medication and thereby supports treatment adherence.
We took over the CardioCare software, developed it further and successfully brought the product to market in regulatory terms as a medical device in 5 different languages. This included software development, technical documentation, verification and approval.
Challenge
CardioCare had to be approved as a medical device under the European Medical Device Directive (MDD). The central requirement was therefore that the software fully met the regulatory requirements for a medical device: demonstrable safety, a standard-compliant development process and complete technical documentation.
A particular requirement was the medication management. When an app reminds patients to take their medication, this function has to work absolutely reliably. A missing or incorrect reminder can have immediate consequences for their health. Robustness was not a matter of comfort here, but a safety requirement.
On top of that came the handling of highly sensitive health data. Blood pressure, cholesterol levels, pre-existing conditions, medication plans and the biomarkers captured via wearable sensors are especially worthy of protection. Reliably protecting this data was the top priority throughout the entire development process.
Process
We implemented data security within our information security management system (ISMS) certified to ISO 27001. Communication between the apps and the backend is encrypted throughout, authentication uses an established procedure, and sensitive data is stored securely and backed up regularly.
Result
“QuickBird Medical developed the digital platform CardioCare together with us and supported us with the medical device certification under the MDD. The team around Malte and Stefan implemented the functionality of the medical device software and, in doing so, created the technical documentation in accordance with ISO 13485 and IEC 62304. Their commitment made a decisive contribution to CardioCare meeting all regulatory requirements of the MDD. The product can be connected to several FDA-cleared wearable sensors, which enables the capture of digital biomarkers as part of clinical studies. We are extremely satisfied with the result and look forward to a continued successful collaboration.”
DR. ROMAN SCHENK
Managing Director and Board Member, Recardio Inc.
Screenshots
Mobile and Web Application
Future
CardioCare is currently being prepared for global expansion. The application is intended to meet the regulatory requirements of further international markets. We considered this perspective in the architecture and the medical device documentation from the very beginning, so that the expansion can build on a solid foundation.
