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Microscan Hosts Webinar on Simple Steps for Meeting FDA UDI Coding and Labeling Requirements for Medical Devices
OMRON Automation - Americas Posted 03/25/2016
Microscan, a global technology leader in barcode, machine vision, verification, and lighting solutions, announces that it will host a live educational webinar titled “Simple Steps to UDI Compliance” – a review of the FDA’s UDI mandate to standardize product serialization and labeling of medical devices sold in the United States. The presentation and question-and-answer session with Microscan UDI expert Barbie LaBine are both free to attend and will take place during a live 30-minute web session on Wednesday March 30 at 10 A.M. PDT (Seattle) / 1 P.M. EDT (Boston).
Meeting requirements of the FDA Unique Device Identification (UDI) rule is priority-one for today’s medical device manufacturers. A final rule published by the FDA on September 24, 2013, began the countdown for medical device manufacturers who distribute and sell medical devices within the United States (regardless of manufacturing country) to meet strict deadlines for product serialization. Medical device codes and labels must be formatted according to requirements set forth by accredited FDA code issuing agencies. These agencies (GS1, HIBCC, and ICCBBA) provide unique documentation outlining device identification and labeling parameters to satisfy the FDA rule, which varies by agency and by device class. The challenge for medical device manufacturers is to understand this documentation thoroughly to ensure accurate implementation of UDI in their manufacturing processes. This can be a formidable task for the new UDI adopter, and UDI compliance guidelines can be lengthy and complex. Microscan’s experts have reviewed the UDI requirements and parameters of each issuing agency in effort to simplify these steps for manufacturers, and are hosting a webinar to clarify the process of UDI implementation and answer common questions about the UDI rule.
Barbie LaBine, Training Coordinator at Microscan, leads this webinar as a review of high-level concepts related to UDI, suggests basic guidelines for ensuring compliance, and hosts a question and answer session following the webinar presentation to address specific concerns about UDI implementation from webinar attendees. A Certified GS1 Standards Professional, LaBine has provided training to global medical device manufacturers on UDI compliance and UDI code and label verification for the past two years. LaBine comes to Microscan from the industry-leading barcode verification systems manufacturer Label Vision Systems, Inc., (acquired by Microscan Systems, Inc., in August 2015), and now offers a range of training on Microscan technology and applications.
To learn more and to register for the live March 30 webinar “Simple Steps to UDI Compliance,” visit the Microscan website.
Microscan is a global leader in barcode reading, machine vision, and verification technology serving a wide range of automation and OEM applications. Founded in 1982, Microscan has a strong history of technology innovation that includes the invention of the first laser diode barcode scanner and the 2D symbology Data Matrix. Today, Microscan remains a leader in automatic identification and inspection with extensive solutions ranging from barcode reading, tracking, and traceability up to complex machine vision measurement, guidance, symbol verification, and print quality grading.
As an ISO 9001:2008 certified company recognized for quality leadership in the U.S., Microscan is known and trusted by customers worldwide as a provider of quality, high precision products. Microscan is a part of Spectris plc, the productivity-enhancing instrumentation and controls company.