On October 10, 2025, our practice-oriented course on all regulatory requirements for medical software and apps will start the next round of the compact online course. The course language will be in ENGLISH!
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: 10.10. – 17.12.2025
- Conclusion with online-exam and certificate!
DEVELOPMENT AND APPROVAL OF SOFTWARE AS A MEDICAL PRODUCT with a focus on EUROPE
The use of software in medical devices or of software as a medical device offers a wide range of new possibilities for making diagnoses more accurate and designing therapies more efficiently. For example, it is much easier to link data for a diagnosis or to implement new treatment and diagnostic procedures.
Software intended for this purpose is thus also subject to the analogous regulatory requirements and standards that apply, for example, to ventilators or implants. However, classification in this regulatory framework is quite difficult, especially in the case of software, and is often a matter of interpretation. It often boils down to the so-called intended use.
YOUR PREFERENCE as MEDICAL SOFTWARE SPECIALIST
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.
CONTENT
| Module 1 | General regulatory requirements for software for or as a medical device | 10.10.2025 |
| Module 2 | Implementation of IEC 62304 and IEC 82304-1 for medical device software manufacturers | 24.10.2025 |
| Module 3 | Risk management for medical device software – ISO 14971 | 14.11.2025 |
| Module 4 | UX and Usability for Medical Software and Apps – IEC 62366-1 | 01.12.2025 |
| Module 5 | Cybersecurity – IT security for medical devices | 17.12.2025 |
Single modules also available!
Apply for a scholarship by 30.9.2025
10% discount for LISAvienna's network