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 […]
GCP – Good Clinical Practice Read More »
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
PMCF – Clinical Follow-up Read More »
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
EU Declaration of Conformity Read More »
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
In Vitro Diagnostics Read More »
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
Quality Management Read More »
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
Digital Health Applications Read More »
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
