CE remanufacturing: remanufacturing with manufacturer responsibility In CE remanufacturing, the medical device originally labelled as single-use becomes the property of Vanguard and is subsequently restored through a validated remanufacturing process. In accordance...
CE reprocessing of single-use devices means that Vanguard assumes full responsibility as a medical device manufacturer under the MDR. This includes technical documentation, clinical evaluation, post-market surveillance and vigilance. The certification process was...
A total of 36 woody vegetation strips have been established across the arable field. These are divided into three row types: sweet chestnut, fodder trees and standard fruit trees. Within these strips, 55 different woody and herbaceous species have been introduced,...
A Missing Element in the Emissions Framework: The Concept of Scope 4 Scope 4 describes exactly what is missing from the current system: the avoidance of emissions through reuse, repair, or remanufacturing. While Scopes 1–3 measure what companies generate, Scope 4...
Why manufacturers of medical devices cannot do without this standard ISO 13485 is the internationally recognized standard that defines the requirements for a comprehensive quality management system (QMS) for the design, development and manufacture of medical devices,...
“Healthcare is a system-relevant sector, while at the same time having a significant impact on environmental pollution. […] More than 70 percent of emissions in this sector are caused by the production and supply chains of medical devices. It therefore makes perfect...