IEC 62366-1 – How to Successfully Develop Usable Medical Devices
In an era of increasing digitalization and automation, the human-machine interface is becoming an ever-greater focus. Usability and user-friendliness are fundamental prerequisites for the safe and effective use of medical devices. The user communicates with and controls the medical device via user interfaces. These must therefore be designed to support safe, intuitive, and correct use. Risks resulting from application errors should be eliminated or minimized as much as possible. User interface design plays a role not only in products with software. Ergonomic aspects are also part of usability-oriented development. IEC 62366-1 places the application and the user at the center, with a focus on the safety of medical devices.
In this interactive seminar, learn how to optimally meet the usability requirements of IEC 62366-1 and Regulation (EU) 2017/745 on medical devices (MDR) within your company. We will provide you with usability content that is important from a regulatory perspective in the context of medical device development and approval. In the exercises and workshops, you will have the opportunity toimmediatelyput theory into practice.
- Content
- Usability:Objectivesand Benefits
- Regulatory requirements for usability in the EU (MDR 2017/745, IVDR 2017/746) and the U.S. (FDA Guidance Documents on Human Factors/Usability Engineering)
- Introduction to Usability Engineering
- Usability Engineering Process according to IEC 62366-1
- Creating the Use Specification
- Identifyinguser interface characteristics related to safety and potential use errors
- Identifyingknown or foreseeable hazards and hazardous situations
- Selecting hazard-related use scenarios for summative evaluation
- Creating the User Interface Specification
- Creating a plan for user interface evaluation
- Formative and summative evaluation
- User interface of unknown origin (UOUP)
- Usability Engineering File
- Key interfaces: Risk management and design control
- Workshop: User interface design
- Your Benefits
- You will gain an overview of the various regulatory and standard requirements for fit-for-use development:
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)
- DIN EN 62366-1:2021-08 (corresponds to IEC 62366-1:2015 + COR1:2016 + A1:2020)
- You will learn the individual steps of the usability engineering process and receive application-specific solution proposals.
- You will apply the theoretical content covered in practical exercises and workshops.
- You will learn how to successfully implement the usability process in your company as part of a development project.
- Methods
Instructor-led sessions, group exercises, facilitated case studies, practical exercises, individual work, real-world case studies, discussions, live coaching, storytelling.
- Target Audience
- Manufacturers of medical devices and in vitro diagnostic devices
- Regulatory affairs managers
- Quality management representatives
- Software developers
- Product managers
- Risk managers
