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...
By remanufacturing single-use medical devices, Vanguard significantly reduces CO₂ emissions, material consumption, and waste volumes. These climate and resource benefits strengthen both the Carbon Handprint and the wider Environmental Handprint, ensuring that the...
The Reason for the Lawsuit Innovative Health accused BSW of employing tactics that discourage hospitals from using reprocessed catheters supplied by Innovative Health. Biosense Webster was alleged to have leveraged its market dominance to pressure hospitals into...
Legal Framework Establishes the Foundation Decree No. 2025-895 defines the legal framework for the national pilot phase and aligns it with the European Medical Device Regulation (MDR) (EU) 2017/745 and the Implementing Regulation (EU) 2020/1207. Reprocessing...
AMDR publishes procurement policy to protect reprocessing programmes The Association of Medical Device Reprocessors (AMDR) has introduced a new template for hospitals and healthcare systems:the „Reprocessing and Fair Contracting Policy Template“. This document is...
