On September 24, 2013, FDA published the Unique Device Identification System final rule requiring device manufacturers distributing to the United States to carry UDI compliant labels and submit UDI data to the…
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September 19- 20, 2013, Baltimore, Maryland The FDA UDI Regulation will establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized. All manufacturers of medical devices…
September 26, Los Angeles, CA Topics of discussion are inference, certification, and inspection regulations. In addition, drop shipments regulation was released on september 13. It’s open for public comments. LSPediA…
September 23-25, 2013. Las Vegas, NV The world’s largest packaging and processing event in 2013 delivers innovations to advance your business objectives. PACK EXPO Las Vegas 2013 will bring together…
Serialization is a companywide initiative that spans multiple business units including engineering, operations, RA, QA, QC, supply chain, services, and IT. The sheer complexity of the project can be overwhelming…
The serialization and ePedigree project has many touch points with various operations. Approaching the project without a proper plan and the skillful project management bears the risk of scope creep, budget…
Effective January 1, 2015, manufacturers, wholesalers, and distributors are required by the California Pharmacy Pedigree Law to ship serialized products and track the product movement using ePedigree communications. Wholesalers and…
Tangent Medical is on track to launch a commercial product in March just four years after the company’s humble inception in Ann Arbor, Michigan. That is lightning fast in the…