How to develop usable medical devices successfully
Two-day practical course
With increasing digitalisation and automation, the human–machine interface moves ever more into focus. Usability—and broader user friendliness—is a prerequisite for the safe and effective use of medical devices. Users communicate with and control the device via the user interface (UI); therefore, UIs must be designed to support safe, intuitive, and correct use. Risks arising from use errors should be eliminated or reduced as far as possible. UI design is not limited to software products—ergonomics are also part of usability-driven development. IEC 62366-1 puts the user and the use context at the centre, emphasising device safety.
In this interactive seminar, you will learn how to meet the usability requirements of IEC 62366-1 and Regulation (EU) 2017/745 (MDR) in your organisation. We cover usability topics relevant to development and conformity assessment. In exercises and workshops, you will immediately put theory into practice.
- Content
- Usability: purpose and benefits
- Regulatory requirements for usability in the EU (MDR 2017/745, IVDR 2017/746) and USA (FDA Human Factors/Usability Engineering guidances)
- Introduction to Usability Engineering
- Usability Engineering process per IEC 62366-1
- Creating the Use Specification
- Identifying user-interface characteristics relevant to safety and potential use errors
- Identifying known or foreseeable hazards and hazardous situations
- Selecting hazard-related use scenarios for summative evaluation
- Creating the User Interface Specification
- Creating a User Interface Evaluation Plan
- Formative and summative evaluations
- User interface of unknown provenance (UOUP)
- Usability Engineering File (UEF)
- Key interfaces: Risk Management and Design Control
- Your Benefits
- Get an overview of the regulatory and normative requirements for usability-driven development:
- Regulation (EU) 2017/745 (MDR)
- Regulation (EU) 2017/746 (IVDR)
- DIN EN 62366-1:2021-08 (corresponds to IEC 62366-1:2015 + COR1:2016 + A1:2020)
- Learn each step of the Usability Engineering process with application-oriented solutions.
- Apply the taught concepts directly in practical exercises and workshops.
- Understand how to implement the usability process as part of a development project in your company.
- Get an overview of the regulatory and normative requirements for usability-driven development:
- Methods
Presentation, workshops, real-life examples, discussion, storytelling
- Target Audience
- Manufacturers of medical devices and in vitro diagnostics
- Regulatory Affairs professionals
- Quality management representatives
- Software developers
- Product managers
- Risk management specialists
