This half day course will help you gain an understanding about the requirements on clinical data and clinical evaluation.
📅 Next session: Online, 09 October 2026 (held in Swedish)
🕘 Time: 09.00 – 14.00 CET
💰 Price: 4300 SEK for Swedish Medtech members, 6100 SEK for non-members (excluding tax)
Our upcoming clinical evaluation course, in cooperation with Swedish Medtech, provides knowledge about the clinical evidence requirements for getting a medical device CE marked.
This course covers:
Clinical evaluation – an overview
Regulatory context
Clinical data
Device-specific adaptation
Equivalence
Post-market clinical follow-up (PMCF)
Step-by-step guidance on performing a clinical evaluation
Quality and regulatory professionals in the medical device industry, and other medical device professionals interested in this topic.
You’ll walk away with an understanding of the clinical evaluation process, its connection to risk management and post-market surveillance, and knowledge on the requirements for clinical evidence.
The course is held in Swedish (course materials in English) and led by Cecilia Emanuelsson, Senior Principal Consultant.
Questions? Contact: academy@aurevia.com
Learn more and register