Beschreibung
This course provides you with in-depth knowledge of the clinical evaluation of medical software in accordance with the requirements of the European Medical Device Regulation (MDR) and the associated guidelines.
You will learn how to plan, collect, document and analyze clinical data specifically for medical software. Also you will learn how to create a high-quality clinical evaluation report for regulatory purposes.
The course highlights the special features of software development in the context of clinical evaluation and shows how this fits into product development and post-market surveillance.
SEMINAR CONTENT
- Regulatory requirements for medical software
- Classification of software as a medical device
- Clinical evidence and clinical performance of software
- Special requirements of the MDR for medical software
- Clinical evaluation for medical software
- Evidence of safety and performance
- Collection and analysis of clinical data for software
- Structure and preparation of the clinical evaluation report
- Specific aspects of clinical trials with software
- Regulatory framework for software studies
- Design of studies for algorithms and AI-based products
- Involvement of ethics committees and authorities
- Integration into the product life cycle
- Role of clinical evaluation in software development
- Post-market surveillance and continuous evidence generation
- Handling updates and changes to software
PARTICIPANTS
This course is aimed at developers, quality managers, regulatory affairs specialists and other professionals working in the field of medical software.
Your Trainers from Gouya Insights GmbH & Co KG
- Priv. Doz. Dr. Ghazaleh Gouya Lechner | expert in clinical trials and assessments
- Sandra Scheidl, Msc. | Director clinical program
COSTS
- Early bird (until 4 weeks before the seminar): Euro 260,- (excl. VAT)
- Standard (starting 4 weeks before the seminar): Euro 305,- (excl. VAT)
- incl. seminar documents as PDF and a certificate of participation
- Overview of all discounts
LOCATION: ONLINE
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. 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.
