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Navigating Current Challenges with Sterilization Capacity Constraints

Navigating Current Challenges with Sterilization Capacity Constraints

Navigating Current Challenges with Sterilization Capacity Constraints In recent years, the medical device industry has faced growing sterilization capacity constraints. The primary causes are.

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QTS Renovation: A Major Transformation for Future Success

QTS Renovation: A Major Transformation for Future Success

QTS Renovation: A Major Transformation for Future Success In 2023, Cretex Medical | Quality Tech Services (QTS) embarked on a remarkable journey of transformation with the completion of a.

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UDI Regulation Compliance: First Phase Guidance Document Issued

UDI Regulation Compliance: First Phase Guidance Document Issued

Compliance to the UDI regulation includes the FDA public database, GUDID. The first phase of the Global Unique Device Identification Database (GUDID): Guidance for Industry document is now available..

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DuPont Tyvek Transition Update

DuPont Tyvek Transition Update

DuPont Tyvek Transition Update DuPont is transitioning Tyvek® 1073B and Tyvek® 1059B to manufacturing lines that use the latest flash-spinning technology to help ensure greater continuity and.

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UDI Rule Announced

UDI Rule Announced

Unique Device Identification (UDI) Final Rule was announced by the FDA on September 20, 2013. The rule was published in the Code of Federal Regulations as of September 24, 2013. Implementation for.

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