Innokas Medical has launched free webinar series to share ideas and experiences around medical device quality and regulatory matters. In our 8th webinar we will discuss about Clinical Evaluation of Medical Device Software. Welcome to join us!
Clinical Evaluation of Medical Device Software
WHEN & WHERE:
Thursday 25th March 9:00 - 10:00 (Finnish time) @ online Teams meeting (detailed information on how to dial in will follow before the event to registered participants)
LANGUAGE OF THE EVENT:
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!