Laws 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.
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