Certified Human Factors & Usability Engineering Medical Devices (German, Online)

In the interactive remote training course “Certified Human Factors & Usability Engineer Medical Devices”, you will learn all the human-centered content that is relevant from a regulatory perspective in the course of medical device development and approval over four afternoons from 1:00 pm to 5:00 pm. Practical examples from the world of medical technology are used to clarify and consolidate the theoretical content. Specifically, the seminar covers the following content:

• Context of use analyses (intended use, use environment, user profiles)
• Usage requirements analysis (from user needs and requirements to system specifications)
• Development of usage scenarios and use-related risk assessment
• Development of standard-compliant usability files (usability engineering files / human factors validation reports) in accordance with DIN EN 62366-1 and FDA-2011-D-0469
• Preparation, organization and implementation of formative and summative usability tests and evaluations (verifications, validations)
• Development of acceptance criteria and implementation of root cause analyses
• Usability reporting and traceability
• Networking the usability engineering process with risk management and technical development
• Human factors & usability engineering in an international context USA, China, UK

Our special service: prepared webinar documents and the equipment required for the practical exercises will be sent to you by post in advance. 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.

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.

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.

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:

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

The regular costs for the two-day seminar amount to a total of 1,290.00 Euros plus VAT or 1,535.10 Euro incl. 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.

Our seminar management Madeleine Kessler will be happy to answer your questions.