Medical Device Serialization Requirements

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CFR - Code of Federal Regulations Title 21 - Food and …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=821&showFR=1

MEDICAL DEVICE TRACKING REQUIREMENTS Subpart A - General Provisions Sec. 821.1 Scope. (a) The regulations in this part implement section 519(e) of the Federal Food, Drug, and Cosmetic Act (the act), which provides that the Food and Drug …

Pharmaceutical Serialization: An Implementation …

https://literature.rockwellautomation.com/idc/groups/literature/documents/wp/lifesc-wp001_-en-p.pdf

pharmaceutical, medical device and consumer packaged-goods manufacturers to track and trace products across the supply chain. This white paper gives in-depth descriptions of …

Drug Supply Chain Security Act (DSCSA) | FDA

https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa

The Drug Quality and Security Act (DQSA) of 2013 -- Law outlines critical steps to build a system to identify and trace certain prescription drugs as they are distributed in the …

Ten Frequently Asked Questions about Serialization

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

Why Serialization Faqs Are Timely. Serialization is one of the biggest information technology (IT) challenges to affect the pharmaceutical sector in the last decade. In a global landscape of constantly evolving regulatory, …

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 101. Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been …

Medical Device Tracking | FDA

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

Medical Device Tracking. Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the Food and …

Is the medical device industry ready for serialisation?

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

Many manufacturers are expressing interest in ‘connecting’ their devices and taking advantage of artificial intelligence (AI) and other available technologies. That being said, both the medical device …

Medical Device Traceability | Wipotec

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

Serialization of Medical Devices. ... Although not mandated by UDI requirements, aggregation of medical devices is another pillar of optimal medical device traceability. …

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. Blog / By Darragh McMorrow. The clock is well as truly ticking on the introduction of the new EU MDR (Medical Device Regulations). The process of …

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