Description
This seminar will be held in German!
This basic course covers the most important aspects of clinical investigation and clinical evaluation in accordance with European medical device regulations and applicable guidance documents.
You will learn how to plan, generate, document, analyze clinical data and produce a high quality clinical evaluation report that is acceptable to regulatory authorities and notified bodies. We will show you how the process fits into the development of a medical device or IVD and also the post-market aspects of clinical evidence.
Seminar contents
- Regulatory framework
- Clinical evidence
- Clinical benefit
- Clinical performance evaluation
- Clinical evaluation
- Proof of compliance with the essential requirements for safety and performance
- What data do I need for the clinical evaluation?
- Composition of the clinical evaluation report
- What is a clinical trial?
- Regulatory framework for clinical trials
- Ethics Committee
- BASG
- Documents for submission of clin. examinations
- Clinical trial protocol
- Rationale of clinical trials
- Study design and definition of endpoints
Date
28.11.2025 from 9:00 to 16:30
Participants
This basic course is also suitable for participants without prior knowledge or with little prior knowledge. For industry newcomers and start-ups, this course offers an optimal introduction to the legal framework for the clinical evaluation and testing of medical devices and IVDs.
Costs
- Early booking (up to 4 weeks before the seminar): Euro 540,- (excl. VAT)
- Standard (from 4 weeks before the seminar): Euro 610,- (excl. VAT)
- incl. seminar documents as PDF and a confirmation of participation
- All seminar discounts at a glance
Your trainer
- Priv. Doz. Dr. Ghazaleh Gouya Lechner, expert for clinical trials and assessments, Gouya Insights GmbH and Co KG
- Further information about our trainers
Venue: ONLINE!
