In co-operation with Swedish Medtech

Clinical evaluation is on ongoing procedure to collect, appraise and analyse clinical data of pertinence for the medical device. There is a strong relationship between clinical evaluation, risk management and post-market surveillance.

Topics

• Clinical evaluation – an overview
• Regulatory context
• Clinical data
• Device-specific adaptation
• Equivalence
• Post-market clinical follow-up
• To perform a clinical evaluation – step by step

Educational goals

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.

Recommended prior knowledge

The course is developed for participants who have a basic knowledge of medical device development and medical device legislation.

Course presentations

Course material will be in English, verbal presentation and discussions in Swedish.

Course leader

Cecilia Emanuelsson, Principal Consultant