Healthcare is a strong-selling business and in many countries of the world even the most high-selling branch. The quality and accessibility of medical devices is one key to success. The medical device industry is a multi-billion market and constitutes a central pillar of especially the German-speaking, US American and the Far Eastern economic areas.
Similar to other branches like the automotive industry, an increasingly high percentage of the value added is produced by the information technologies and software in particular. Unlike other branches, medical technology is still missing uniform standards for product development as well as education. This shortfall leads to
- Numerous hazards caused by faulty medical software: The German Federal Institute for Drugs and Medical Devices, for example, has to inform about risks in connection with such products nearly every working day
- Differing interpretations by manufacturers and notified bodies of the potential requirements on the development of medical software
- Sometimes excessive but little productive documentation of processes and products, which reduces the productivity of medical device manufacturers and may prevent small companies from entering the market
- Missing recognized and certified education and training opportunities for those involved in medical software development
The “Certified Professional for Medical Software” initiative intends to take on these challenges and has set itself the objectives described here.