Medical Device App Development for Proveca
Dosage calculator app case study
The goal was to take three existing paper-based dosage charts and build a dosage calculator app for initiating treatment on a specific new medication & switching from alternative medication. The app met the criteria for software as a medical device (SaMD) and therefore needed to comply with the requirements to the Medical Device Directives and go through CE marking.
HCPs would use one calculator app to replace three dosing charts that allows them to calculate the correct dose in either ml or mg based of weight of child. To ensure the widest audience reach, the app would be available for iOS, Android but also as a web-based calculator. The Proveca brand values would need to be clearly reflected in the user interface (UI) and the software technical file would need to be produced so that the app could be CE marked. The app is currently available in different territories and there are plans to introduce a number of different language variations.
Medical App Compliance
We worked closely with the team at Proveca to take the app through the CE marking process by producing the necessary paperwork and technical file that was required to support the app’s application for CE marking. This included a process of clinical validation and verification which means that the Proveca app is classified as a medical device app under the Medical Device Directive (MDD) and registered with the MHRA as a Class I device.
All references to specific medication has been removed from the app imagery
The app has been a great addition to help healthcare professionals to easily check dosing. Other product information has also been extremely useful for pharmacists wishing to see lists of excipients.
Overall, we have been extremely satisfied in the finished product and would highly recommend Genetic Digital as a professional medical device app development agency.
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