• includes West VeriSure stoppers and
Flip-Off seals and Ready-to-Fill vials
• sterilized components are delivered in packaging appropriate for aseptic filling
The new European MDR EU 2017/745 lays down rules concerning med devices being placed on the market for human use. As part of a global harmonization effort, many aspects of the new MDR are aligned with requirements noted in the U.S. FDA CFR's, as well as the recent release of ISO 13485:2016, an international standard governing medical device quality management systems.