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New Certification for U.S. Based Wearable ECG Recorder Means Extended Monitoring Capabilities in Europe

New Certification for U.S. Based Wearable ECG Recorder Means Extended Monitoring Capabilities in Europe
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Jim Demaso , Doug Linquest , Global Instrumentation , Business Development , European Medical Device Regulations , Drug Administration , உலகளாவிய கருவி , வணிக வளர்ச்சி , ஐரோப்பிய மருத்துவ சாதனம் ஒழுங்குமுறைகள் ,

Colorful Seal Assurance Supports EU MDR for Device Packaging


GOLD AWARD Expanding the Use of Flexible Packaging Chameleon for Tyve by Paxxus, Inc.
The product was designed to address the requirements of the European Medical Device Regulations (MDR) going into effect in May of 2021 that the integrity of a package is “clearly evident to the final user.”
Additionally, ISO 11607-1 further clarifies that the inspection takes place immediately prior to aseptic presentation. This presents a challenge for uncoated (or coated) Tyvek sealed to PET/PE of Ny/PE which shows minimal contrast at the seal, making it difficult to identify anything but gross seal defects.
Chameleon “allows the user to readily evaluate the quality of a seal when used with uncoated Tyvek. Prior to opening, the seal shows as a darker color when viewed through the film side. Once the package has been peeled open, a vivid colored seal indicator presents on the Tyvek with a contrasting white seal indicator on the film,” says the company. ....

European Medical Device Regulations , Green Chameleon , ஐரோப்பிய மருத்துவ சாதனம் ஒழுங்குமுறைகள் , பச்சை பச்சோந்தி ,