Companies need to master the digital transformation quickly and successfully. This also applies to medical device manufacturers because, after all, their future depends on it. Many companies make severe mistakes during this transformation (see section 4). This article provides managers with a quick overview of the possibilities of digital transformation and gives seven tips to make it…
DetailsThis article outlines the five most common misconceptions and mistakes medical device manufacturers should avoid during clinical evaluation and how to avoid them.
Medical device manufacturers are obliged to systematically collect and evaluate clinical data, both before and after the approval of their products. The EU Medical Device Regulation (MDR) has increased the requirements for the scope and quality of the required clinical data. This article provides you with an overview of the regulatory requirements and gives tips…
DetailsWhat is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article
DetailsThe term summative evaluation can be translated as “final evaluation.” A summative evaluation checks at the end of the development phase whether users can operate a device or a user interface safely. This article provides an overview of the regulatory requirements for the “summative evaluation” (sometimes also referred to as “summative assessment“) and gives you…
DetailsThe ISO 10993-17 standard is part of the ISO 10993 series of standards on biocompatibility. ISO 10993-17 describes the procedures for Toxicological Risk Assessment. In the fall of 2023, a comprehensive standard revision was published after over 20 years. Medical device manufacturers should know, This article will help.
DetailsLaws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. This article presents the most important regulatory requirements and provides tips for implementation.
DetailsThe qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays.
DetailsIn vitro diagnostic medical devices (IVDs) are medical devices used to analyze samples derived from the human body. Typically, these products are reagents, kits, instruments, and devices. Software can also be considered as an IVD regarding its intended purpose. When “approving IVDs,” manufacturers must comply with many regulations, laws, and standards.
DetailsIncluding a free download of the chapter structure for the Clinical Evaluation Plan The Clinical Evaluation Plan is one of the most complex documents in the technical documentation. Alongside the Clinical Evaluation Report, the Clinical Evaluation Plan (CEP) is the document most frequently criticized by notified bodies. Even experienced clinical experts typically need 60 working…
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