Master Data Management
UDI-Unique Device Identifier Regulatory Services
On September 24, 2013, the U.S. Food and Drug Administration (FDA) announced the new requirement to identify medical devices that affect its safe and effective use through the use of UDI.
Medical Device manufacturer companies have to create and maintain the Unique Device Identifier (UDI) which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date.
UDI will be a unique numeric or alphanumeric code consisting of two parts, DI – identifies the labeler and the specific version or model of the device and PI – variable portion of UDI which is combination of lot/batch number, serial number etc.
Transitions to UDI Program
In order to handle your evolving UDI Challenge, setting up a strategic UDI program as well as implementing a flexible and extensible framework capable of handling multiple agencies will be unavoidable on your journey to global UDI compliance.
Before setting up your UDI program, several strategic considerations must be made:
Optimize your process accurately to capture data, review your inventory management processes
Automation can help manual data entry and reduce errors and costs
Establish and educate a cross functional team
Educate stakeholders within the company about the benefits of UDI is essential to realize its full potential.
Consider engaging Supply Chain, Sales IT, Operations, and Clinicians will help facilitate this change.
Services provided by our professional staff:
Gap assessments for UDI compliance, looking at your device and label.
UDI training and project management:starting with a workshop, we will help your staff get up to speed on the required process, documentation, and technology changes.
Help you implement UDI processes into your quality management system and production operations.
Identifying the right accredited UDI agencies.
Ensuring UDI data is formatted correctly for submitting to GUDID and later, EUDAMED
Guidance on supply chain management and validation to support UDI implementation.
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DKNSB Medical Device Consultants is backed by 20 years of experience with the aim to provide Technical and Regulatory Support to Medical Device Manufacturers from India and Overseas.
Objective: Hassle-Free Regulatory Approval for Indian Manufacturers, Foreign Manufacturers and Importers.