The medical device domain is heavily regulated by national laws and international standards. To be able to develop software for medical devices requires in-depth knowledge of the requirements these standards imply on software development practices.
In addition to basic software engineering know-how, a medical device software developer needs to understand the principles of quality management, document management, the risk management process, usability engineering and other regulatory requirements. The CPMS program provides the training necessary for software developers to qualify for this challenging work.
ICPMSB Certified Professional for Medical Software – Foundation Level
Board / Organization
International Certified Professional for Medical Software Board (ICPMSB e.V.)
1) CPMS Foundation Level,
2) CPMS Advanced Level “Software Development” (in preparation)
3) CPMS Advanced Level “Process Management” (in preparation)
Course: English, German | Exam: English, German
Software Designers, Software Developers, Software Architects, System Analysts, Project Managers, Quality Managers, Medical Device Developers, Product Managers, Regulatory Affairs Managers
Basic knowledge in software development and medical device is a requirement for attending the training. The Foundation Level certificate is required for further steps of the CPMS program.
Certified Professional for Medical Software is offered as a SMEX Exam as a paper-based exam after Training or during our regularly scheduled public examinations.
32 questions, multiple-choice, 60 minutes, minimum score 60%