Upcoming trainings
Date: 16 April 2027, 9.00-14.00
Place: Online (held in Swedish)
Price: 6100 SEK (excluding VAT)
Topics
- Clinical evaluation – an overview
- Regulatory context
- Clinical data
- Device-specific adaptation
- Equivalence
- Post-market clinical follow-up
- How to perform a clinical evaluation – step by step
Trainers
Cecilia has extensive knowledge of medical devices with specific focus on patient safety aspects from a clinical perspective. Her experience covers MDD/MDR and IVDD/IVDR devices of all risk classes, including implants and medical device software. Cecilia has a scientific background with many years of experience from academic research.
Target group
Quality and regulatory professionals working with medical devices, and other medical device company employees interested in the topic. The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.Objectives
After the course, participants will have a general knowledge of the requirements on clinical data and clinical evaluation. They will also have a basic understanding of how to perform a clinical evaluation.Additional information
The course costs 6 100 SEK. For Swedish Medtech member companies, the course costs 4 300 SEK. All prices are excluding local VAT. Course material will be in English, with verbal presentation and discussions in Swedish.
The course will also be held on November 19, 2027.