Together with our cooperation partner Swedish Medtech we would like to discuss about Clinical Evaluation of Medical Device Software. Thus, we've been invited to hold an online event with Swedish Medtech to share our ideas and experiences. You're all warmly welcomed to join!
WEBINAR INFORMATION | Clinical Evaluation of Medical Device Software:
Are you unsure about when to start Clinical Evaluation for your Medical Device Software? Or how to approach this big task? How far will you company’s internal competence get you or who else will you need onboard to reach the finish line?
The role of Clinical Evaluation in regulatory compliance is growing considerably. With technology developing fast, the guidance offered by the authorities is tied to a more general level on what you need to confirm with Clinical Evidence. For Medical Device Software, the Clinical Evaluation focuses on 3 separate aspects: Valid Clinical Association, Technical Performance and Clinical Performance. The questions to ask in order to find the right Clinical Data for gathering the necessary Clinical Evidence, are different for each aspect. Together they build a clear picture of the validity of your device for its intended purpose.
Come and join in to learn more about how to plan and execute the Clinical Evaluation for your Medical Device Software!
- WHEN & WHERE: 16th February at 10:00-11:00 (Swedish time) as online event
- REGISTRATIONS: This webinar is open and free for anyone to attend! The original webinar promotion can be found from Swedish Medtech's website and the registration can be made through their page as well.