Mentally healthy through pregnancy
Summary
mamly
Pregnancy is without a doubt a life-changing event. Besides all the feelings of happiness, there is also great potential for insecurity, anxiety and even depression.
With targeted exercises, mamly helps to reduce these uncertainties and contributes to a mindful lifestyle. After an initial query of the current mental state via questionnaire, the app offers various modules that impart knowledge and train the mindfulness of the users.
Psychologically stressed users also have the option of making appointments with professional coaches and conducting video consultations via the app. Via the backend, coaches can view information about the users and set their consultation times individually.
Challenge
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.
Process
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.
Result
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!”
Screenshots
Future
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.
Further Projects
You want to realize an app idea?
Contact us without obligation. We’ll take a look at how much effort it would take and in what time frame it would be possible to implement it. We can also provide technical feedback on the sticking points of your project.
QuickBird Medical
QuickBird GmbH
Nymphenburgerstr. 13-15
80335 Munich
