Innovation in Medical Device - Are You ready for UDI? | Page 7

Medical device manufacturers are smart to focus first on UDI compliance:
put in place the systems, processes and governance to ensure you achieve
compliance with the new UDI regulations prior to pursuing other strategic
benefits. Continued market access for your products is at stake.
But companies that look over the horizon will understand that UDI
can be an enabler for many benefits beyond compliance. These
benefits could include:

FDA Unique Device Identification (UDI) System

Deliver More than Compliance
with your UDI Program

• Improved


Patient Safety: More accurate and timely responses to
adverse events; Reduced medical errors; Improved post-market
surveillance; Improved responsiveness to medical recalls

• More


Secure and Efficient Supply Chain: Fewer errors in order management
and fulfillment; Reduced counterfeiting; Improved inventory control

• Improved


Internal Efficiencies: Streamlined labeling operations;
Simplified product numbering schemas and manufacturing
execution; Tighter integration between other business systems

•  ccelerated International Access: Improved product registration
A
process; Increased visibility into global product configurations
• Better


Responsiveness to Customer Requirements: Global product
classification; Certified data pools and Synchronization of accurate data

The trick will be to implement your compliant UDI system with enough ‘hooks’
to enable these future downstream benefits – without allowing the program to
get sidetracked by building the initial system to be everything for everyone.

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