How should we envision the system you are developing?
Hampe: We initially learn from a pilot case, an X-ray machine where we benefit from the expertise of our partner Siemens Healthineers. We plan to design the system to essentially manage any risk. It is meant to allow modular safety and risk documentation. Many modern medical devices are developed as a monolithic architecture, which is particularly the case for risk documentation.
Heidenreich: The approval process is also monolithic, which is something that is impossible to manage for auditors. The Medical Device Regulation (MDR), the new regulation from Brussels, is far more complex as it pertains to the approval documents. Now everything must be re-approved.
Hampe: It’s something we simply must improve because the process no longer works for any of the parties involved - the regulatory agencies, the manufacturers, the medical device users. Everyone has reached their breaking point and is looking for powerful alternatives to the current processes.
Heidenreich: We want an electronic approval process. Thanks to an AI-based solution, the future scenario should look something like "enter the medical device documentation and out comes the CE mark". That is our vision for the next 20 years.