In this seminar, you will gain an overview of the regulatory framework and familiarize yourself with the specifics of placing medical software on the market. The requirements for classification and conformity assessment procedures of medical software in the most important markets will be shown to you in a practical manner and using current examples.
You will learn about all phases of the product lifecycle of medical software, starting with development, through initial marketing, to software maintenance (i.e. updates and bug fixes). We will show you what is important when placing products on the market in the most important markets and how you can integrate the required processes into your quality management system in a meaningful way.
Participants:
This basic course is suitable for participants with no or little previous knowledge. For newcomer and start-ups, this course offers an optimal introduction to the legal framework for medical software development.
This basic course is part of our online course: Medical Software Specialist!
Focus:
Basic regulatory requirements in Europe and the USA
- Overview of regulatory frameworks for medical software
- Decision support for the classification of software as a medical device
- Special features of standalone incl. mobile medical applications („APP“) and embedded software
- Classification principles for medical software
- Exercises:
- How to use the digital health policy navigator (USA-FDA)
- How to classify your medical software / app
- General Safety and Performance Requirements (Template-Matrix)
Selected requirements
- Product development processes
- Digressions
- Agile development process
- EU Regulations MDR / IVDR – General Safety and Performance Requirements