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At this point we share exciting information with you time and again. This can be regulatory news, reports on projects or new methods. We would be pleased if you would drop in regularly!
I’ve never had to do usability before – so why do I have to now?
Marvin Kolb | 15. Sep 2022 | Formative Usability Evaluation | Summative Usability Evaluation
Are you a medical device manufacturer and have to meet usability requirements for your medical device since the introduction of the MDR? Are you wondering why this is the case? You want to know what exactly has changed and what…
Deep Dive: MDR and Usability
Marvin Kolb | 09. Sep 2022 | Best Practices Usability Engineering
You are established as a manufacturer of medical devices and are now wondering why you suddenly have to meet some Usability requirements for your product with the introduction of the Medical Device Regulation? What exactly has changed? Where can you…
What does the MDR mean in terms of Usability?
Marvin Kolb | 26. Aug 2022 | Basic Terms | Formative Usability Evaluation
What is the MDR? When did it come into force? Where exactly does the MDR apply and what are the Usability requirements for your medical device? How do you ensure that these Usability requirements are also compliant with the MDR?…
Usability Engineering for Medical Devices according to IEC 62366-1
Marvin Kolb | 15. Aug 2022 | Best Practices Usability Engineering
How exactly does the Usability Engineering process work? What does IEC 62366-1 require of you? What exactly do you have to prove? In this article, we clarify exactly these questions and take a step-by-step look at the Usability Engineering process.…
What is a „formative Usability Evaluation“?
Marvin Kolb | 29. Jul 2022 | Basic Terms | Formative Usability Evaluation
What exactly is a formative Usability Evaluation? Is it mandatory? How is it different from a summative Evaluation? How can your product benefit from one (or more) formative Evaluation(s)? What is the best possible approach for formative Evaluations and which…
Lecture: “Efficient and safe – IVD-R compliant through Usability Engineering”
Marvin Kolb | 22. Jul 2022 | Formative Usability Evaluation for IVDs
You could not attend the MedTec Summit this year and missed the lecture “Efficient and safe – IVD-R compliant through Usability Engineering”? Our Lead User Experience Researcher Medical Dr. Jonas Walter has recorded this exact lecture for you. The lecture…
Summative Usability Evaluation according to IVDR – Your Checklist
Marvin Kolb | 08. Jul 2022 | Summative Usability Evaluation for IVDs
You are already planning your Summative Usability Evaluation according to IVDR and want to make sure you get it done without missing any important steps? Do you want an overview of the steps you need to successfully execute the Summative…
Is there a „Usability Obligation” for medical devices?
Marvin Kolb | 10. Jun 2022 | Basic Terms | Formative Usability Evaluation
Is Usability Engineering mandatory for your medical device? Which regulations and standards must be observed? Can you benefit from a possible Usability Obligation and how do you manage to comply with the obligation in the most targeted and uncomplicated way…
How to prepare your Usability Testing for IVDs
Marvin Kolb | 25. May 2022 | Formative Usability Evaluation for IVDs
You know that you have to demonstrate Usability Testing for your In Vitro Diagnostic Device (IVD) according to the In Vitro Diagnostic Device Regulation (IVDR), but you don’t know yet how exactly you have to prepare for it? Then…
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Are you interested in a quick, goal-oriented and respectful cooperation at eye level? Get in touch and together we will find out how we can support you.
Are you interested in a quick, goal-oriented and respectful cooperation at eye level? Get in touch and together we will find out how we can support you.
