FDA registration of medical devices Many of you will have heard that FDA approval is necessary to legally sell medical devices in the USA. These procedures include a Premarket Notification 510(k) or a Premarket Approval (PMA). There is also another, lesser-known procedure. The so-called De Novo Program of the FDA. But “only” having product approval […]
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EU Declaration of Conformity for Medical Devices and IVDs What is an EU Declaration of Conformity? Regarding medical devices and IVDs, the EU Declaration of Conformity states that the requirements specified in the MDR or IVDR for the product concerned have been met. For this purpose, the manufacturer issues the EU Declaration of Conformity under
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App on Prescription – Digital Health Applications (DiGA) What was unthinkable not too long ago is now becoming a reality: telemedicine and digital health applications in Germany. These DiGAs are apps that patients can install on their smartphones, and their costs are covered by standard care, i.e., by statutory health insurance funds. Since these apps
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Usability of Medical Devices – Formative Evaluation and Summative Evaluation What does usability mean? The IEC 62366-1 provides a good definition for this question. According to it, usability describes the characteristics of the user interface that facilitate use and thereby enable effectiveness, efficiency, and user satisfaction in the intended use environment. The user interface is
Approval of Class I Medical Devices What are Medical Devices? Simply put, medical devices are products that fulfill a medical purpose and primarily act physically to perform their function. To precisely determine whether a given case involves a medical device, the definition must be checked: “Medical device” means any instrument, apparatus, appliance, software, implant, reagent,
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Preparation for a Clinical Evaluation In the first part of our blog series on clinical evaluations, we introduce you to the basics of the topic. In subsequent posts, we will delve deeper together, showing you step-by-step which requirements must be met. Feel free to also read Part 2 of the blog series. Click here for
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What does biocompatibility mean? The definition provides the following information: “Ability of a medical device or material to perform with an appropriate host response in a specific application [ISO 10993-1]”. Sounds too complicated? We think so too. A host response could be skin irritations, for example. Generally speaking, these are undesirable reactions / side effects.
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The Responsible Person – PRRC The MDR and IVDR are causing many changes in medical technology. The focus of both regulations is clear: patient safety! This results in the influences on technical documentation, adjustments to the quality management system, and the associated, sometimes enormous, workloads that have already been extensively discussed in the industry. But
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