Webinar

Usability of Medical Devices

Regulatory requirements and practical tips

Available Dates & Times

● 19. November 2024 > 10:00-11:30 h CET

Description

The webinar will provide a general overview about the Usability Regulatory Landscape, including Risk Management, MDR, IVDR and applicable standards. The Usability Engineering Process as required by IEC 62366 will be described briefly, including the prerequisites required for “grandfather devices”, i.e. for the User Interface of Unknown Provenance (UOUP). A special focus will be on usability evaluation methods. Finally, usability requirements from the legislation and guidelines as well as practical tips will be presented for topics including instructions for use (IFU) and the Summary of Safety and Clinical Performance (SSCP).

Net price

Free of charge

Overview of covered topics

Purpose of the webinar

Participants will get:

Who should attend

Basic knowledge required

Presenting experts

Dr. Anna Spehl

Senior Consultant
AKRA TEAM GmbH

Dr. Andrew Gibson

Team Leader - Senior Clinical Consultant
AKRA TEAM GmbH

Torsten Gruchmann

Managing Director
Use-Lab GmbH

Stephanie Schwenke

Senior Project Manager
Use-Lab GmbH

Dr. Anna Spehl

Senior Consultant
AKRA TEAM GmbH

Dr. Anna Spehl

Senior Consultant
AKRA TEAM GmbH

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