Learning Objectives and Contents
In the English-speaking interactive Webinar “Human Factors & Usability Engineering Medical Devices”, within 4 afternoons (01:00 p.m. – 05:00 p.m., UTC +2) all human-centered content is taught that is relevant from a regulatory perspective in the course of medical device development and approval. The Webinar is held remotely via Online Live Sessions. Using real examples from the world of medical technology, laboratory devices and combination products as well as practical exercise sessions, the theoretical content is constantly clarified and consolidated. Specifically, the seminar includes the following contents:
- Context of Use Analysis (Intended Use, Use Environment, User Profiles, Task Analysis)
- User Requirements Engineering (from user needs and requirements to system specifications)
- Development of Use Scenarios and Use-Related Risk Analysis
- Preparation of standard-compliant usability files (Usability Engineering Files / Human Factors Validation Reports) according to IEC 62366-1 and FDA-2011-D-0469
- Preparation, organization and execution of formative and summative Usability Tests and Evaluations (verification, validation)
- Test Acceptance Criteria and execution of Root Cause Analyses
- Usability Reporting and Traceability
- Linking the Usability Engineering Process with Risk Management and Technical Development
- Human Factors Engineering all around the world (aspects to consider regarding special markets like China, UK, USA)
Our special service: You will receive a detailed seminar script in the practical USE-Ing. seminar folder. In addition, our experts will be available to answer your questions by phone or e-mail for 7 days after the end of the seminar.
Certificates as Proof of Qualification
Upon successful participation, you will receive a certificate of attendance documenting the taught content and your acquired knowledge. In addition, as an official training provider of the UXQB®, USE-Ing. enables participants to acquire the internationally recognized certificate “Certified Professional for Usability and User Experience – Foundation Level (CPUX-F)” during the seminar. The certificate certifies that the certificate holder is familiar with the basic terms and concepts from the field of usability and user experience and is acquired through a 90-minute written examination using multiple-choice questions. If desired by the participant, the UXQB® certification exam “Certified Professional for Usability and User Experience – Foundation Level (CPUX-F)” is associated with additional exam costs of 300,- Euro to the regular seminar costs. Further information about the certificate and the exam can be found here.
Target Group
The seminar “Usability Engineering in Medical Technology” is aimed at all stakeholders involved in the user-centered development, design and evaluation of medical technology products, laboratory equipment or combination products (both physical and digital).
As a product manager, regulatory affairs manager, project manager or marketing manager, you will gain an overview of the regulatory requirements and will be able to prepare standard-compliant usability documentation in the course of medical device approval.
As a product developer, UI designer, UX / usability expert, design engineer, electrical engineer, software developer or consultant, you will learn how to formatively and summatively test your technical products with users and reflect this knowledge back into product development.
The number of seminar attendees is limited to 15 participants in order to ensure optimal support and knowledge transfer. In the course of a constructive and motivated group cooperation, we always pay attention to a heterogeneous composition and appropriate selection of participants in our seminars.
Webinar Leaders
Your lecturers have years of experience in both academic research and teaching, as well as in human factors engineering design and consulting. They look forward to your participation:
Dr. rer. nat. Julia Moritz (User Research & Usability Expert)
Dr.-Ing. Benedikt Janny (Human Factors & Medical Devices Expert)
Seminar Schedule
The detailed schedule of the webinar can be found below:
Day 1
- Welcome, introduction and thematic introduction
- Expectations and pain points of the participants
- Basics and terms of human-centered product development (ISO 9241 family of standards)
- Terminology in human factors & usability engineering for medical devices
- Overview of relevant laws and standards in medical device design (MDR, DIN EN ISO 14971 : 2022, IEC DIN EN 62366-1 : 2021, IEC/TR 62366-2 : 2016, DIN EN ISO 13485 : 2021)
- Human Factors & Usability Engineering in an international context (USA FDA: FDA-2011-D-0469, China NMPA: YY/T 1474-2016, UK MHRA: Guidance Document)
- User Research and Context of Use Analysis – Development of the Use Specification (Intended Use, Use Environment, User Profiles, Task Analysis) + Practical Exercise 1
Day 2
- User Requirements Engineering – from User Needs to Requirements to System Specifications + Practical Exercise 2
- Development of use scenarios and use-related risk assessment by means of PCA analysis + Practical exercise 3
Day 3
- Recap Day 1
- Technical User Interface Design for Medical Devices and Equipment (Design Principles, Heuristics, Prototyping) + Practical Exercise 4
- Usability reporting and documentation – standard-compliant preparation of all relevant documents of the usability file (usability engineering file)
- Formative and summative usability evaluations (from verification to validation) – organization and execution
Day 4
- Formative Usability Evaluations + Practical Exercise 5
- Summative Usability Evaluations and Root Cause Analyses + Practical Exercise 6
- Usability Engineering of the accompanying documentation – human-centered testing and design of the Instructions for Use
- Relevant aspects of human factors & usability engineering in the context of post-market surveillance
- Seminar Wrap-Up
Participation fee / costs
The regular costs for the two-day seminar amount to a total of 1,290.00 Euros plus VAT. We grant discounts under the following special circumstances:
- 10 % early bird discount for binding registration 2 month before start of seminar
- 20 % from the second participant of a company
- 30 % for active customers of USE-Ing.
Please note that only one discount can be claimed per participant.
Questions
Our seminar leader Dr. Julia Moritz will be happy to answer your questions.
