What is needed for Clinical Evaluation of Medical Device Software?

En av vår nätverkspartner, Innokas Medical, bjuder in till ett kostnadsfritt webbinarium den 16 februari 2021.

Språket kommer vara engelska.

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!

Presenter: Satu Päiväläinen, Specialist, Clinical Affairs and IVD at Innokas Medical Ltd.

Praktisk information
Datum: 16 februari 2021
Tid: 09:00 - 10:00
Det kommer finnas tid för frågor efter seminairet.
Plats: via länk som du erhåller ett par dagar före eventet

Anmäl dig via länken >>

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