Usability of medical devices according to IEC 62366-1 - normative requirements and implementation

You will learn how to systematically develop medical devices that are fit for purpose and safe to use. You will learn how to avoid user errors through the clever design of medical devices. You will receive specific information on the efficient implementation of normative requirements for the usability of medical devices.

• Legal basis, in particular MDR and IVDR
• Structure and requirements of IEC 62366-1:2015
  • Terms and basics
  • Usability engineering process
• Linking usability engineering with risk management in accordance with ISO 14971
• Methods for analysing the context of use (user and usage environment)
• Embedding usability engineering in innovation projects and product development
  • Usability specification
  • Analysing use errors with hazard-related use scenarios
  • Linking use errors and risk analysis
  • Integration of use scenarios in system and software requirements documents
  • Creating user interface requirements for the user interface specification
• Planning, conducting and evaluating usability tests
  • As formative user interface evaluations
  • As summative user interface evaluation and part of validation
• Other sources - ISO 9241 series of standards, AAMI HE 75
• Additional requirements of the FDA in relation to usability engineering / human factors engineering

Certificate of Attendance from TÜV SÜD Academy

Usability engineers, user experience designers, quality assurance, research and development, product management, risk analysis, regulatory affairs staff

• The content of the seminar corresponds to the current status of the revision/harmonization.
• The seminar deals with internationally valid standards and is also suitable for implementation abroad.
• The seminar is part of a modular further training course. After successfully completing the advanced modules, you can acquire this recognized qualification:
  • Specialist Medical Software - TÜV Foundation Level

Alle Online Termine dieser Veranstaltung werden vonder TÜV SÜD Akademie GmbH in Deutschland durchgeführt. Bei Onlinetrainingsgelten daher zusätzlich die Allgemeinen Geschäftsbedingungen undPrüfungsordnungen sowie Datenschutzinformationen der TÜV SÜD Akademie GmbH. BeiRückfragen stehen wir Ihnen gerne unter [email protected] zurVerfügung.