MDSAP – Medical Device Single Audit Program: an Audit for the FDA and Four other Authorities In this blog post, we explain what MDSAP is all about. We will explain its structure, process, and important aspects of preparing for this audit. Are you interested in our services in the area of the Medical Device Single […]
Medical Device Vigilance What Does Vigilance Mean? The term vigilance means constant attention. For medical devices and IVDs, it is about manufacturers implementing a vigilance system that enables them to identify and report reportable or serious incidents and trends from collected data. For example, the data is collected as part of complaint handling or post-market
Fundamentals – Quality Management in Medical Technology What is the Purpose of a Quality Management System? The fundamental idea is to establish a system that enables a continuous, iterative increase in quality. This system is designed to prevent a previously achieved quality level from being lost. It should provide a framework that systematically addresses errors
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