📢 Medical device manufacturers - listen up!
📅 Since September 24, 2023, all device labels & subsequent packaging, called Unique Device Identification (UDI), must comply with the updated standards set by the FDA (among other regulatory bodies).
🧠 Did you know: If you aren't properly marking and verifying UDI labels, not only are you not in compliance with these standards, but it puts your business at risk for audits, fines, and product recalls.
👉 In our free on-demand webinar, discover how accurate UDI label marking and verification impact patient safety, regulatory compliance, and overall efficiency.
🌎 Learn from real-world examples of verification success and cautionary tales, and uncover best practices to implement a cost-effective and compliant barcode scanning and verification process.
AGENDA
I. Introduction
II. Understanding UDI Label Verification and Compliance
• Overview of UDI labels and their relationship between ISO standards, FDA guidelines, and GS1/HIBCC labeling requirements
• Specific ISO requirements for barcode marking and verification to ensure compliance
• Importance of accurate UDI label verification for patient safety and regulatory adherence
III. Common Challenges in UDI Label Verification
• Identifying the most prevalent challenges faced during UDI label verification
• Highlighting the potential consequences of non-compliance
• Real-world examples of UDI pitfalls arising from inadequate verification practices
IV. Case Studies: UDI Pitfalls - Compliant vs. Non-Compliant Verification
• Presenting real-world case studies of companies that faced UDI label verification challenges
V. Strategies to Overcome UDI Label Verification Challenges
• Best practices for ensuring accurate UDI label verification
• Implementing a robust barcode scanning and verification process
• Utilizing advanced technology and solutions for reliable verification
VI. Barcode Printers, Scanners, and Readers for UDI Label Verification
• Types of UDI printers
• Types of Barcode Scanners and Readers
• Key Features to Look for in UDI Barcode Scanners
Who Is This Webinar For?
Medical device manufacturers
The FDA's updated UDI standards (and, by extension, this webinar) apply to all companies involved in the production and labeling of medical devices.
What is considered a medical device? Learn more from the FDA. Medical devices can be as simple as tongue depressors and bedpans or as complex as programmable pacemakers and closed-loop artificial pancreas systems. Additionally, electronic products that emit radiation and have medical uses or claims are also classified as medical devices. Examples of such products include diagnostic ultrasound machines, x-ray machines, and medical lasers.
Label houses & label machine builders
These standards also apply to professionals involved in labeling medical devices and their outer packaging, such as labeling houses and label machine builders.
This webinar is for all experience and awareness levels
People unaware of UDI requirements and need to be caught up to speed
People aware of UDI requirements and need a refresher
Companies that need to update UDI marking
Companies that need to update UDI verification
Presenter
Jason Mack
Meet Jason Mack, an accomplished Advanced Sensing Sales Manager for Microscan & Omron Americas. With a remarkable 10-year tenure as a UDI / Life Science Device Expert, Jason has collaborated extensively with top US medical device companies, focusing on label review, printing, and inspections. Take the chance to learn from this industry authority and gain valuable insights into advanced sensing technologies and UDI compliance strategies.
Host
Todd Huber
Here's your Airline host with the most! Meet Todd Huber, the Automation General Manager at Airline Hydraulics, leading a team of product specialists and field application engineers. His 20+ years of experience in the industrial automation industry includes sales, product management, and applications engineering with numerous equipment manufacturers in sensors, HMIs and I/O, panel meters, and machine safety.