by Marvin Kolb | 13.5.2022 | Basic Terms, Basic Terms, Summative Usability Evaluation
What exactly is a summative evaluation or summative usability evaluation? How does it differ from a formative evaluation? How does the summative evaluation proceed and what do you have to consider? What exactly is evaluated? If you have asked yourself one or more of...
by Marvin Kolb | 14.4.2022 | Basic Terms, Basic Terms, Formative Usability Evaluation for IVDs, Summative Usability Evaluation for IVDs
What is the IVDR? When does it come into effect? Where exactly does the IVDR apply and what are the Usability requirements for your IVD? How do you ensure that these Usability requirements are met in accordance with the IVDR? In this basic terms article you will find...
by Marvin Kolb | 18.3.2022 | Basic Terms, Basic Terms, Formative Usability Evaluation
What does the term “user experience” mean? What is the concept behind it? Why is it so relevant for the medical sector? What does the user experience encompass? Why is it so important for your product and how can you improve it? If you have asked yourself...
by Marvin Kolb | 22.2.2022 | Basic Terms, Basic Terms, Formative Usability Evaluation
Poor usability of a medical device can lead to injuries and endanger the well-being of patients or users. For you as a manufacturer, there is also the risk, that your product will not be approved or that you will be held liable for defects in the product. But what...
