Coridian Technologies offers Complete
Unique Device Identification (UDI) Compliance solution for Medical Device
The Business Challenge
The US Food and Drug
Administration (FDA) has issued a ruling that certain medical devices must
conform to a Unique Device Identification (UDI) standard. The NHS has now
released an eProcurement strategy that urges suppliers to adopt UDI in 2015.
If your company manufactures
products that are sold into the US Health marketplace and the NHS, whether
directly or via distribution, then successful Unique Device Identification
(UDI) is crucial to retain your ability to supply.
The FDA calculated the initial
cost of compliance is between 1-8% of revenue. The cost to your company
will depend on: the number of products that need to comply and your readiness
for UDI compliance. With an average
implementation time of 6 months any company not engaging on UDI at an
early stage risks losing their current
sales to the US market and subsequently will lose competitive advantage if
supplying to the NHS.
This will create challenges
for organizations required to conform to this standard, including:
• Understanding the FDA
& NHS UDI requirement – what is the impact of the new UDI compliance
requirements to your business
• Time-line to compliance –
can your organization meet the implementation challenges without impacting your
• The cost of compliance – can your existing systems be adapted to conform to
FDA and NHS UDI requirements and maintain compliance over time
• Data quality – Do you have validation systems in
place to ensure each and every GS1 barcode produced can be validated at every
stage of manufacture and retain appropriate audit trails to meet external
Coridian Technologies offers the
Kodit UDI solution which has been designed to assist you with your FDA
compliance and product information management needs.
In this solution the Product,
Import and Revision Modules can be used by your compliance team to manually
input, mass import, manage and revise all product data before approval within
the system. Once approved the solution
then permits this data to be submitted to a data pool.
This system has review, approve
and submit features built in giving you absolute clarity of which products are
ready for submission and which products have been accepted by the data pool.
The dashboard feature gives a snapshot of your overall progress, while the
audit feature allows you to see who is entering and amending data and who is
accessing the system and what activity they have performed. Once all of your product data has been
approved, submitted and accepted you also have the option to utilize the
accuracy of this data by creating label templates with our built in Template
If support is needed with data
import and label creation, the experienced Coridian Technologies professional
services team is available to assist you.
Coridian also offers and has expertise with any compliant hardware
needed allowing for a full solution including 2D barcode printing, scanning and
Coridian Technologies UDI
Kodit UDI Software Solution
Zebra labeling hardware
Barcode scanning equipment
Dedicated account manager
Ongoing service & tech
Benefits to your Business
The Unique Device Software as a
Service from Coridian Technologies using Kodit UDI software and Fujitsu cloud
infrastructure will deliver a range of potential benefits:
GS1 compliance – Avoids the investment and time required to establish
an in-house GS1 compliant capability for UDI.
The cost of compliance – We estimate the service will reduce your year one
implementation costs of ongoing compliance by up to 50%, achieved by:
the cost of gaining detailed knowledge of GS1 compliance and how that impacts
removing the need to upgrade your
existing service or implement a new on premise solution
reducing the costs of manual processes
reducing the cost of keeping up with GS1
and other standards
reducing the costs associated with
and non – compliance.
Future Proofing your compliance – Future modifications made by the FDA (or NHS or
other agencies) to the UDI requirements will be integrated into Kodit solution
as necessary and delivered to users with an up to date SLA.
Integrated with common customer
ERP systems- single entry of data and
avoiding re- keying effort and errors and non- compliance.
Built-in flexibility – you will be able to increase your label production
in-line with business demand. The service will scale up or down to meet the
demand of both Small to Medium Enterprises as well as Large manufacturers.
Information – Our solution will
capture the necessary information that flows through the process giving you
vital information for audit purposes.
Predictable pricing – Financing options are available so you can have a
predictable monthly expenditure for your UDI compliance solution. IF not financed the solution includes a
one-time start up charge and then a fixed charge linked to your full UDI
Contact Coridian Technologies
directly at 952-227-9147 or email
email@example.com to arrange a meeting to discuss your requirements