The “Certified Professional for Medical Software” initiative works towards the following goals:

• Define a uniform training standard for the target group
• Establish a focussed training which also refers to existing trainings
• Market the training successfully in order to
  • make the job profile “medical software developer” better known
  • help integrating it into basic trainings
  • raise awareness among the employers
  • create a brand
  • make the actual expertise of the graduates transparent
  • become a part of personnel certification

If these goals are achieved, we hope for the following benefits:

• • companies externally and internally (e.g. QA and development)
  • notified bodies
  • training providers and institutions of higher education
  • tool manufacturers and companies (medical device manufacturers)
  • companies and notified bodiesThe training provides a common terminology/language, a common understanding and interpretation which simplifies the communication between

• The training is structured, standardised and documented in such a way that it
  • is comparable
  • can be outsourced
  • helps service providers to attest their qualification to their clients

   

• The training is so practically oriented that it helps to
  • save costs in development and avoid QM overhead costs
  • develop more innovative and safer medical devices

   

• The training contributes to an awareness of high-quality software and conveys the benefit (of the “red tape” associated mainly with the processes and the documentation) to the developers. The point is therefore to communicate the reasonableness of the legal requirements. One aspect hereof is the developers’ insight into the clinical use of their products.