In order to improve patient safety, the FDA created a new regulation requiring the standard identification of every medical device throughout its supply chain journey. To meet this newly proposed regulation for UDI (Unique Device Identification), medical device manufactures and their suppliers must label every product, product version, and product configuration with a unique, 14-digit identifier. What’s more, a wide range of critical device information is required to be submitted to the FDA’s new GUDID (Global Unique Device Identifier Database) to more effectively track adverse events and safety issues to specific products. Not complying with this regulation would bar device sales across state lines, which means that noncompliance is not an option for medical device manufacturers in the US.
Working with the FDA and major medical device manufacturers, PTC has developed an efficient, cost-effective solution to help companies manage UDI submissions and gain compliance, while ensuring scalability to meet future FDA or worldwide requirements for UDI.
The PTC UDI Solution:
The PTC UDI solution combines OOTB technology, services, and training to offer an end-to-end solution for managing UDI submissions.
Learn more about the FDA's recent UDI regulation and how the PTC UDI solution reduces the complexity and cost of compliance
UDI: Complexities of Compliance Article
UDI: Commanding the Complexities Article
Executive Scorecard: UDI Readiness Scorecard
Brief Demonstration of PTC UDI Solution Video
The PTC advantage is fueled by technology solutions that transform the way you create, operate and service products.
Our technology enabled solutions transform the way that products are created, operated, and serviced in the Internet of Things.
Revolutionary ideas available through 50+ strategy, business and technical sessions-from hands-on developer boot camps to customer case studies.
PTC solutions help you tackle the real challenges manufacturers and service providers face every day.
See how PTC can help you optimize the system of people, processes and technology to enable greater service performance. Learn more.
Discover updates on the ThingWorx platform, Axeda applications and partner technologies and services for end-to-end IoT solutions.
Industry leading software technology is at the heart of every PTC solution.
Thousands of Pro/ENGINEER customers have already made the move to PTC Creo Parametric. Learn more.
In education sessions, networking events and Solutions Expo demos at PTC Live Global, June 7-10. Learn More.
PTC Global Services helps the world's leading manufacturing companies realize the promise of PTC solutions.
How to select the right provider to optimize application performance
Access a variety of sessions from the latest curriculum, led by our most experienced instructors at PTC Live Global, June 7-10. Learn More.
Whatever your role in the worldwide PTC community, these resources will deepen and enrich your experience.
Get your questions answered and make new connections with peers and PTC product experts at PTC Live Global, June 7-10. Learn More.
Add to the discussions and showcase your work to product development professionals from around the world.
Support solutions that accelerate and sustain your advantage.
PTC is transforming your online technical support experience. The award-winning eSupport portal homepage provides personalized, fast access to product knowledge and case resolution.
Don't have an Account?
Create an account today
Meet customers, industry thought leaders, IoT innovators and technology experts representing a variety of industries.
PTC Corporate Headquarters 140 Kendrick Street Needham, MA 02494, USA
Phone: (781) 370-5000 Fax: (781) 370-6000