The Unique Device Identification (UDI) system mandated by the FDA is designed to protect patient safety and require the proper identification of medical devices. UDI Compliance Solutions is the gold standard software that you can use right now to comply quickly and efficiently.Learn More
Rather than creating, orienting, training and supervising a new compliance team internally, you can leverage our experience and world class software solutions to save resources and amplify your profitability quickly.Contact Us Now
This easy demonstration proves that UDI Compliance Solutions is the gold standard of compliance software for simplicity, affordability and performance!Try It Now!
Keys To Your Continued Success
The recently mandated FDA Regulations now required for all medical devices purchased or utilized in the United States have been on the horizon for a long period of time. Now that the official version of these regulations is finally in place with clearly defined deadlines and guidelines for GUDID compliance, your continued success requires adaptation to this set of important labeling policies. UDI Compliance Solutions simplifies compliance by providing a cloud-based reliable software package that does all of the following for our clients:
Simple Form Interface For Q&A Style Data Entry
Clear and Concise Online Support Services
Detailed Direct Human Support For All Compliance Questions
Fully Integrated Error Checking To Insure Complete Documentation
Continual Product Updates Covering New FDA Requirements
Flat Rate All Inclusive Pricing From Form Completion To Official Filing
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The FDA deadlines serve to give medical device companies a target date to shoot for, however
What makes UDI Compliance Solutions Experts In This Field?
Our team is comprised of a few dedicated people with more than eighty combined years of experience in the fields of Medical Labeling and FDA compliance. When we first became aware of the new proposed UDI Compliance regulations and GUDID system that the FDA was considering, we got to work on creating solutions that would benefit our own existing clients once these new policies became legally mandated. What we discovered is that we were properly positioned to do even more than that. UDI Compliance Solutions is the only distributor if Kodit software in the United States, the simplest central platform possible for your company to immediately comply with all of the new requirements disseminated by the FDA. Better than just showing you how or doing part of the work for you, our software guides you step by step from the start of your UDI form to completion and takes care of all the complicated GUDID filing requirements with just a few keystrokes. See for yourself with our free online demonstration right now.
The mission of UDI Compliance Solutions is to assist qualified clients with all aspects of UDI compliance and GUDID filing to improve your organization’s efficiency and provide your consumers with the security intended by FDA regulations.
Some UDI compliance issues will require detailed human interaction and expert support to deal with anomalies in the regulations or unique item parameters. Other simpler filings are better managed by an automated software platform. UDI Compliance Solutions provides both for our clients. A robust cloud-based software package and the personal liaison interaction to complete even the most complex GUDID applications.
Our team of compliance experts provide clients with award winning service that goes beyond the expected areas of software support and general questions. We are here for you and provide customers with a detailed knowledge base that serves as an important resource for many in the medical labeling industry.
UDI Compliance Strategic Partners
Many years of working with top tier companies in the labeling industry have allowed UDI Compliance Solutions to establish terrific relationships with a wide array of strategic partners. During that time we have diligently made every effort to enhance the reputation of our clients, vendors and colleagues by providing reliable information, forward-thinking business planning, mutually beneficial goals and a cooperative entrepreneurial style. If you would like to discuss areas of synergy with your own ventures, please contact us. We are always open-minded toward new initiatives and ideas.