With this recognized certificate you can prove your qualifications and competences in the field of medical software!
- 5 modules = 5 days (9am-4.30pm – ONLINE)
- Next start: January 30 until April 23, 2025
- Conclusion with online-exam and certificate!
This course introduces the world of regulatory terminology and explains why the intended use is fundamental from the outset for anyone developing software in the context of a diagnosis or therapy of disease. And why proper classification is as important as the product idea itself.
Our online Medical Software Specialist course will provide you with the step-by-step knowledge to navigate this complex environment. This includes sound know-how on the relevant laws, standards and regulations, as well as on how to integrate the software lifecycle into the quality management system and the risk management system.
The developers of software for or as medical device(s) are ultimately more than just software developers. They create software products which, in addition to a clinically proven benefit for patients, must not entail any unacceptable risk. They must therefore meet all legal requirements for medical devices.
Manufacturers of software for or as medical device(s) therefore need specialists who have sound technical knowledge on the one hand and competence in regulatory and clinical matters on the other. These specialists are in great demand! The medical device market is one of the most innovative and fastest growing markets in recent years.
Apply for our scholarship – 2 x € 490,-!
Content
| Module 1 | Development of software for medical devices | January 30, 2025 | 9am-4.30pm |
| Module 2 | Implementation of IEC 62304 and IEC 82304-1 for medical device software manufacturers | March 7, 2025 | 9am-4.30pm |
| Module 3 | Risk management for medical device software – ISO 14971 | March 21, 2025 | 9am-4.30pm |
| Module 4 | UX and Usability for Medical Software and Apps – IEC 62366-1 | April 11, 2025 | 9am-4.30pm |
| Module 5 | Cybersecurity – IT security for medical devices | April 23, 2025 | 9am-4.30pm |
Single modules also available!
The course concludes with an online exam (multiple choice) and an individual final discussion on the contents of all modules. After successfully passing the exam, you will receive your personal certificate.
With this recognized degree, you provide proof of qualification and competence in the field of medical-use software:
- You have the necessary knowledge about the desired functions and any risks of software.
- You are able to include the legal and normative foundations already during the software development process.
- Your know-how ensures user-friendliness and risk minimization.