This seminar will be held in English.
The development of standalone software such as mobile medical applications but also the integration of software as a component in medical devices means a complex challenge for many medical device manufacturers in the intersection of technology, regulations and clinical evidence.
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.
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.
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
- How to use the digital health policy navigator (USA-FDA)
- How to classify your medical software / app
- General Safety and Performance Requirements (Template-Matrix)
- Product development processes
- Agile development process
- EU Regulations MDR / IVDR – General Safety and Performance Requirements
- Early bird (until 4 weeks before the seminar): Euro 490,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 540,- (excl. VAT)
- incl. seminar documentation as PDF and certificate of participation
- Martin Schmid, Managing Director & Senior Consultant at en.co.tec Schmid KG
You only need a laptop with camera and microphone for our ONLINE seminars. Our eLearning platform works on all operating systems in the web browser (eg Firefox, Safari or Chrome). You will receive the seminar documents and the link to the virtual seminar room in time by email. The seminar will be interactive – similar to a face-to-face seminar – i.e. you can ask your questions to the lecturer, there will be exercise examples and also the possibility to exchange ideas with the other participants.
Click here for online registration.