In addition to the technical implementation, mamly was also an exciting challenge from a regulatory point of view. mamly was to become a medical device according to the Medical Device Regulation (MDR). QuickBird Medical, as the legal manufacturer, brought the product to market and took over the entire regulatory responsibility. Thus, our customers could fully concentrate on their core expertise in the field of science, marketing, sales and user support of the application.
For QuickBird Medical to take on the role of the legal manufacturer, our ISO 13485 certified quality management was used to agilely develop the app. We thus took over the development within the software lifecycle according to IEC 62304, risk management according to ISO 14971, usability engineering according to IEC 62366 and the clinical evaluation of the product.
In addition to regulatory issues, it was important for us to focus on implementing a user-friendly app that (prospective) mothers would enjoy using every day. Here, we worked closely with the experts from the Institut digitale Frauengesundheit (IfdfG) and defined next steps in weekly coordination meetings.
mamly has successfully entered the market as a medical device in compliance with all regulatory requirements. The product stands out with its modern, intuitive design. Intensive testing and quality assurance during development also resulted in an extremely robust product.
We are particularly pleased with the feedback from IfdfG’s CEO at the end of the project: “The app turned out great and was explicitly highlighted as outstanding in the IT Security Pen Test. QuickBird Medical was a reliable partner to us throughout the project, and mamly is now going live ahead of schedule! QuickBird Medical was also indispensable in regulatory, MDR and GDPR issues. A great, straightforward, interdisciplinary and professional team. We are already planning further development and will also want to implement new projects with QuickBird Medical. Many thanks to the whole team!”
Of course, we continue to support the product in order to fulfill our obligations as a manufacturer and to ensure patient safety and performance. This allows the IfdfG to fully focus on its core competencies: sales and medical support for its users. mamly is also constantly being further developed and supplemented with additional functions and modules. We are pleased about the continued smooth cooperation with our customer in this project.