Medical Device Serialization

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Unique Device Identification System (UDI System) | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system

The FDA provides device labelers with two options for submitting data to GUDID: manual data entry using the GUDID web application (for entering data for one device at a time) and HL7 SPL...

Serialization and Traceability of Medical Devices | Arca

https://www.arcalabelingmarking.com/en/medical-devices-serialization-and-traceability/

MEDICAL DEVICES SERIALIZATION AND TRACEABILITY. The international needs for patients’ safety have led many countries to adopt …

Serialization 101 | Healthcare Packaging

https://www.healthcarepackaging.com/news/traceability-serialization/article/21220731/serialization-101

Serialization assigns a unique serial number linked to information about the product origin, batch number, and expiration date, to each saleable unit of each …

Ten Frequently Asked Questions about Serialization

https://ispe.org/pharmaceutical-engineering/may-june-2019/ten-frequently-asked-questions-about-serialization

To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure …

A Guide to Serialization For Pharmaceutical Manufacturers

https://tulip.co/blog/serialization-for-pharmaceutical-manufacturers/

Medical Devices & DiagnosticsManufacture high-quality medical products at any level of compliance Production Type High-Mix Discrete AssemblyError-proof …

Medical Device Tracking | FDA

https://www.fda.gov/medical-devices/postmarket-requirements-devices/medical-device-tracking

Manufacturers of a tracked device must establish a written standard operating procedure (SOP) which includes a method for tracking the device throughout distribution and a …

Medical Device Traceability | Wipotec

https://www.wipotec.com/us/medical-device-traceability

Medical device serialisation and aggregation. TQS solutions are multifunctional modular machines that enable reliable medical device traceability. In addition to seamless …

Is the medical device industry ready for serialisation?

https://www.medicalplasticsnews.com/news/are-you-ready-for-it/

While UDIs are an excellent starting point, serialisation is the crucial next step that will allow the industry to better manage the flow of product through the supply chain, guard against counterfeiting, and …

Medical Device Sterilization: Methods Explained, Compared

https://esenssys.com/methods-of-medical-sterilization/

There are multiple types of chemical sterilization in the medical field. The most commonly used are: Ethylene Oxide (ETO) Sterilization Chlorine Dioxide (CD) Gas …

The UDI and Serialisation Requirements of the New EU …

https://slcontrols.com/en/the-udi-and-serialisation-requirements-of-the-new-eu-mdr/

The UDI and Serialisation Requirements of the New EU MDR. The clock is well as truly ticking on the introduction of the new EU MDR (Medical Device Regulations). The process of implementing this new EU directive started …

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