Recently, the Food and Drug Administration released final guidance concerning the labeling of medical devices that are distributed for use in the United States. This guidance requires a Unique Device Identification (UDI) label to be affixed to each of these devices.
The UDI label contains several pieces of information that will lead to a higher quality of information, a reduction in errors and more accurate reporting in the medical field. Arbour Group's experienced professionals are extensively trained to evaluate a client's readiness as well as assist with UDI Compliance.
Unique Device Identification (UDI) number consists of the following components:
The Device Identifier (DI): a fixed portion of the UDI that serves as a device identifier and also gives the labeler and the specific model and version of the device.
The Production Identifier (PI): a variable portion of the UDI that identifies the following information when included on a device's label:
- The lot or batch number of manufacture
- The serial number of the device
- The date of manufacture
- The expiration date of the device
- Any distinct identification code required by §1271.290(c) for the device
If you have questions about UDIs or UDI compliance, the experts at Arbour Group are here to help. We have a client base of over 250 pharmaceutical, medical and biotechnology clients across the globe, and are the leader in compliance assistance. Contact us today for more information on how we can assist your organization.
Arbour Group has provided us with competent validation project leadership that has enabled us to complete projects in a timely and cost effective manner.
The use of Arbour’s validation product greatly facilitated the process.
The regulatory assistance provided by Arbour Group has enabled us to enhance our compliance profile with life sciences customers.
Their Managed Services for software development and quality assurance play a key role in controlling business risk and reducing costs.
Arbour Group provided effective validation services to us and were a valuable part of the overall success of our company-wide ERP implementation.
Their integration into our multi-phase ERP roll out was seamless and assured us of comprehensive regulatory compliance.