The 4-day interactive online training for professionals focussing on the regulatory human factors & usability engineering process. Option to acquire the CPUX-F certificate.
A context of use analysis, also called User Research, is the beginning of the user-centered development process. The goal is to understand the future Users, their Workflows and Working Environments in detail. As part of the requirements analysis, our experts derive relevant usage requirements (User Needs & Requirements) from this usage context. In accordance with the normative requirements, we offer our customers the use of observational, questioning and testing techniques. The method spectrum includes basic techniques such as protocols, audio and video recordings, but also the use of advanced technologies such as Eye Tracking. In the context of Hospitation and Questioning, we collect both qualitative and quantitative data for our clients, for example through context interviews, user surveys or focus group interviews.
According to ISO 14971, manufacturers of medical devices are obliged to analyze and minimize as far as possible the risks potentially arising during product use. Within the framework of usability engineering, so-called interaction- or use-related risks and Hazardous Situations must therefore be taken into account in the development of medical devices. This results in so-called hazard-related use scenarios. Our experts support you in the planning, implementation and evaluation of such Use-related Risk Assessments, enable the combination with technical risk analyses and, if required, prepare the documentation necessary for you from a regulatory point of view.
Want to ensure the Safe Use of your medical device?
Contact us to learn more.
The information gathered in the analysis is bundled in the Specification. This is done at the requirements level by deriving User Requirements and User Interface Specifications, which can be bundled and specified in the form of a requirements specification. Workflow analyses are used to develop Task Models and transfer them into regulatory Use Scenarios. But also the development of a regulatory relevant Use Specification document can be summarized here. The result: Strengths and Weaknesses of the medical device and the workflow become visible and can be optimized through intelligent product design.
Are you wondering how the transfer between qualitative research and technical specification succeeds?
Our experts support you in the development of your Requirements Specification.
Both the FDA Guideline and the IEC 62366-1 stipulate the safeguarding of usability, both during development (formative) and at the end of development (summative), through the targeted use of Usability Evaluation Methods. Our experts perform expert-based Inspection Methods, such as Cognitive Walkthrough or Heuristic Evaluations, as well as Usability Tests with test persons or support you with yours. The recruitment of representative Test Users is an important and regulatory obligatory factor. With our test person pool of over 900 Medical Professionals, we are able to represent every medical discipline and recruit them for tests. The standard-compliant evaluation and comprehensible presentation of the study results are, of course, also part of our repertoire.
Would you like to test the Usability of your medical products, devices or combination products with Healthcare Professionals before placing them on the market?
We look forward to supporting you.