Unique Device Identification Compliance
Meeting compliance requirements for the FDA Unique Device Identification (UDI) rule is priority-one for today’s medical device manufacturers and labelers. With compliance dates on the horizon for new classes of devices, businesses must be proactive in ensuring standardized product serialization and update their labeling procedures at a rapid pace, or forfeit the right to participate legally in the marketplace.
Don't miss the recording of our UDI webinar from the 5th of May - Read More
The pressure to meet this demand can be daunting, and understanding the available UDI documentation can also be a formidable challenge to the new UDI adopter. Below you can down load a whitepaper that offers guidelines for simplifying each step toward UDI compliance and answers common questions about the UDI rules.
This whitepaper includes:
• What is Unique Device Identification?
• Who is required to participate?
• What is the difference between a DI and a PI?
• How do I register with the FDA and GUDID?
• What is the timeline to become compliant?
• What are the different classes of devices and their requirements?
RedLine has several White Papers below that discuss these issues and more
Watch the videos below that discuss the Microscan Verifier range designed for UDI barcode verification.