IEC 62366-1: Usability Engineering of Medical Devices
At the end of this training,
- You will learn how to systematically develop medical devices that are fit for use and safe to use.
- You will know how to avoid user errors through clever design of medical devices.
- You will receive concrete information on the efficient implementation of the normative requirements for the usability of medical devices.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Usability Engineers, User Experience Designers, Quality Assurance, Research and Development, Product Management, Risk Analysis, Employee Regulatory Affairs
- Legal basis, in particular MDR and IVDR
- Structure and requirements of IEC 62366-1:2015
- Terms and basic principles
- Usability Engineering Process
- Linking usability engineering with risk management according to ISO 14971
- Methods for analyzing the context of use (user and usage environment)
- Embedding usability engineering in innovation projects and product development:
- Use Specification
- Analyze use errors with hazard-related use scenarios
- Relationship between use errors and risk analysis
- Integration of use scenarios in system and software requirements documents
- Setting Up User Interface Requirements for the User Interface Specification
- Planning, implementation, evaluation of usability tests
- As formative user interface evaluations
- As a summative user interface evaluation and part of the validation
- Other sources – ISO 9241 series of standards, AAMI HE 75
- Additional requirements of the FDA regarding usability engineering/human factors engineering
Usability is an important safety and performance feature of medical devices. The Medical Devices Ordinance (MDR, 2017/745) and the In-Vitro-Diagnostics Ordinance (IVDR, 2017/746) place significantly stricter requirements on usability, which EN 62366-1:2015 + AMD1:2020 does not fully cover either. However, EN 62366-1 + AMD1 represents the state of the art for many requirements. All of these regulatory requirements call for usability engineering in the development process of medical devices. In this seminar you will learn to understand and implement the requirements of the standard. What's more, good usability also offers the chance to stand out from the competition and to create enormous added value with the right methods. This seminar shows how to implement the regulatory requirements and at the same time create the greatest possible added value through good usability. With the help of workshops, the learned content is put into practice.
- The IEC 62366 standard aims to reduce errors caused by inadequate medical device usability. Such errors have become an increasing cause for concern. IEC 62366 is a process-based standard that aims to help manufacturers of medical devices to design for high usability.
- The contents of the seminar correspond to the current state of revision/harmonization.
- The seminar deals with internationally valid standards and is also suitable for implementation abroad.
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Participants will receive a certificat eof attendance from the TÜV SÜD Academy.
Learners must obtain a copy of the relevant ISO/IEC standard(s) to reference during the course. These standards can be purchased through the American National Standards Institute (ANSI) at www.ansi.org, the American Society for Quality (ASQ) at www.asq.org, or any other authorized distributor of international standards.