On April 26, 2024 our practice-oriented course on all regulatory requirements for medical software and apps will start in a compact online course.
With this recognized certificate you can prove your qualifications and competences in the field of medical software!
- 5 modules = 5 days (9:00-16:30 – ONLINE)
- Next start: April 26 – June 7, 2024
- Conclusion with online-exam and certificate!
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 purpose.
This course introduces the world of regulatory terminology and explains why purpose classification 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 | Development of software for medical devices | April 26, 2024 | 9am-4.30pm |
| Module 2 | Implementation of IEC 62304 and IEC 82304-1 for medical device software manufacturers | May 08, 2024 | 9am-4.30pm |
| Module 3 | Risk management for medical device software – ISO 14971 | May 24, 2024 | 9am-4.30pm |
| Module 4 | UX and Usability for Medical Software and Apps – IEC 62366-1 | June 03, 2024 | 9am-4.30pm |
| Module 5 | Cybersecurity – IT security for medical devices | June 07, 2024 | 9am-4.30pm |
Single modules also available!
Participants
- Medical device manufacturers whose products contain software or are software products in their own right, from the areas of regulatory affairs, quality management, systems and software engineering, usability engineering, requirements engineering, project management, risk management, product management, IT, management,
- Service provider / supplier in the medical technology,
- Consultants for medical software
- Newcomer & Start-Ups