Med Device Link Newsletter - Aug 2023
LexisNexis Reed Tech
Regulatory compliance and product data management solutions for medical device manufacturers and pharmaceutical labelers
Hello!
The upcoming long Labor Day Weekend is just around the corner, providing everyone with a well-deserved opportunity to unwind and recharge.
As we gear up for the fall season and embrace new opportunities, we want to remind you that we are here to support you in staying updated with UDI requirements. If you need any assistance with updating FDA GUDID records or preparing for UDI submissions to global health authorities, please don't hesitate to reach out to us via email at [email protected].
Webinar Recording
Ask the Experts: Basic UDI-DI
Gary Saner and Ronald Boumans answer questions and provide scenarios regarding Basic UDI-DI for EU EUDAMED.
Industry News & Blogs
GMDN Code Updates to AccessGUDID and OpenFDA
We wanted to pass along a communication from FDA concerning: FDA to update AccessGUDID Database and OpenFDA
Resources are available on the GMDN website to help labelers identify alternatives to the obsolete term codes. Questions? If you have questions or need further assistance, please contact the FDA UDI Help Desk?
Understanding FDA Exemptions to UDI Requirements
To simplify your UDI discovery process, we've developed a user-friendly flowchart that can assist you in determining whether your medical device qualifies for an exemption. How does your portfolio align with the exceptions or requirements?
领英推荐
Let's Connect at RAPS Convergence Oct 3-5
Reed Tech will be located at Booth #624
Our upcoming in-person event is scheduled for October 3-5 at RAPS Convergence in Montreal. We invite you to visit our booth (#624) for an exciting trivia game. Additionally, we are thrilled to announce that our very own, Gary Saner, will be delivering a presentation on UDI topics on October 5th at 12:45 pm. We are eagerly anticipating your presence at the event!
Introducing the 'Understanding UDI Series'
Access the 'Understanding UDI Series' for short tutorials and quick reference slides. Learn more about regulations, requirements and timelines for Global Health Authorities. We added a recent update for Australia. How did you score on the quiz??
Questions? Ask the Experts
If your team has questions about health authority requirements, device classes, Unique Device Identification (UDI) data attributes, or related topics, get in touch! We'd be happy to help.