Seminar “Usability & Requirements Engineering”

“Do you want to quickly and systematically identify requirements and concise and compliant usability files?”

How do you know the requirements of your customers and users of your medical device? Just ask? Perform a workshop? No! Henry Ford already knew the answer to that: “If I had asked my customers what they wanted, they would have said a faster horse.”

Teaching objectives and teaching content

The identification of requirements is not a matter of direct inquiries, chance, or of personal preferences. You will learn in the seminar:

  • Process of systematically deriving usage and system requirements
  • Usability specification and user interfaces design
  • procedures for the verification and validation of usability respectively formative and summative usability evaluation
  • Interaction of development, usability engineering, and risk management processes
  • Usability file compliant with IEC 62366 and FDA requirements

Contact us for more information about the next dates, costs, and registration.

Why you should participate in the usability and requirements seminar

1. Speed up development and avoid unnecessary rework and frictions

As a product manager, you will learn to collect comprehensive, precise, and stable stakeholder requirements. You will learn to define the roles of product management, usability engineer, requirements engineer, and developer. A precise definition of tasks, competencies, and responsibilities will help you to avoid friction losses.

As a manufacturer, you can avoid the perpetual re-specifying and touch-up of your products. This will save you valuable time and unnecessary costs. 

2. Develop truly innovative products and increase your market success

In this seminar, you will learn that requirements engineering is a systematical innovation process that will lead to products that your users really need and appreciate. Your new products, that actually deserve the attribute “innovative”, give you the opportunity to achieve market leadership.

3. Meet the legal requirements and avoid regulatory problems

You will avoid problems in the audit specifically regarding ISO 14971, IEC 62366, or IEC 60601-1-6 and FDA requirements. You will learn to verify and validate the usability of your products and to compile a compliant usability / human factors engineering file.

All regulations require that medical device manufacturers have to prove a systematically training and education of personnel – also with respect to usability / human factors engineering.

Target audience

The seminar “Usability, Requirements & IEC 62366” addresses all persons who are involved in the standard-compliant development of interactive medical devices, in particular of medical devices that contain or that are software. This includes

  • Product managers
  • Usability/human and requirements engineers
  • (Software) developers
  • Regulatory affairs and quality managers

The principles of usability and requirements engineering are applicable to any interactive system. However, the examples used in the seminar have a focus on active medical devices.