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 […]
Fundamentals of Post-market Surveillance What is Post-market Surveillance? Post-market Surveillance (PMS) is the English term for the surveillance of medical devices and in-vitro diagnostics (IVDs) after they have been placed on the market. Manufacturers of medical devices and IVDs operate in a strictly regulated environment. This is important because medical technology involves human lives. It’s
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GCP, Good Clinical Practice – Good Clinical Practice According to ICH E6 (R2) and ISO 14155 Good Clinical Practice – GCP – Good Clinical Practice Another term related to GxP. But what’s behind it? Good Clinical Practice (GCP) is based on internationally recognized ethical and scientific standards in the field of clinical trials. It provides
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PMCF: Post-market Clinical Follow-Up – Clinical Post-Market Follow-Up The MDR introduces a number of new terms and abbreviations. One of them is PMCF – Post-market clinical follow-up. In German: The clinical post-market follow-up. But what exactly is it? In this article, we will explain what this term means. You will also learn for which products
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Basics – IVDs in Medical Technology What are IVDs? In Vitro Diagnostic devices (IVDs) are a subgroup of medical devices. In vitro means that diagnostics are performed based on organic processes outside the living organism. Conversely, the term “in vivo” means that something takes place within the living organism. By definition, IVDs are intended for
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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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