Interview with Sang-Il Kim about the SwissCovid App
Which challenges did you face prior to the collaboration with Decomplix?
The Federal Office of Public Health has launched several mobile applications (apps), such as the SmokeFree Buddy App or the Cheminfo. The SwissCovid App is the first app that is considered a Class I Medical Device. Although we were able to draw on the knowledge about Medical Devices within the Federal Office, this was not sufficient for Medical Device Software, which includes apps. This fact presented us with various challenges. For example: What are the legal requirements for a Class I Medical Device? Which standards must be met? And how can all these requirements be integrated into an agile software development process? What documents are required for registration with the Swiss Authority for Therapeutic Products, Swissmedic?
In the current situation, the FOPH has neither the knowledge nor the resources to ensure ongoing compliance. We have therefore procured appropriate services for documentation, consulting and implementation of measures in the field of Regulatory Affairs and Quality Management from Decomplix. Therefore, our team could be supported and we now maintain the conformity of the app.
How did Decomplix help you overcome these challenges?
Decomplix prepared the required documentation within a reasonable period of time and supported the project in all questions concerning the requirements of medical device software for the SwissCovid App. Their experts anticipated existing processes, contributed constructively to the solution finding process and supported the project team with their practical experience in the development and documentation of Medical Devices. As this was uncharted territory for many of those involved in the project, Decomplix’ support created a great added value for everyone.
Which aspect of the collaboration were you most satisfied with?
The expertise and constant willingness to actively tackle challenges are very satisfactory. This went so far that workshops were held with the project managers and developers of the SwissCovid App to analyze, optimize and make the processes relevant for medical devices more efficient.