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Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner
FromGlobal Medical Device Podcast powered by Greenlight Guru
Preparing Your Class II Device for the UDI Compliance Deadline with Gary Saner
FromGlobal Medical Device Podcast powered by Greenlight Guru
ratings:
Length:
23 minutes
Released:
Nov 7, 2019
Format:
Podcast episode
Description
If you are part of an organization developing or producing Class II medical devices, you should know that on September 24, 2016, your UDI submissions are due to the FDA.
“I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner
UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices.
Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics.
“The UDI submission is not a one-time effort.” - Gary Saner
With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order.
Some of the topics you’ll hear discussed on today’s podcast include:
- What UDI is and what information needs to be included in each of its components.
- The timeline of deadlines leading up to now and up to September 2016 as they pertain to different types of devices.
- Some of the challenges that apply to larger and smaller companies when it comes to meeting the 9/24/16 deadline, as well as how the Reed Tech tool can help organizations of all sizes.
- The importance of knowing and understanding the UDI submission process.
- The two submission methods that the FDA has in place.
- Tips and pointers to keep in mind as you go through the submission process.
“I don’t mean to scare anyone, but we only have 78 working days left.” - Gary Saner
UDI stands for “unique device identification,” and the new labeling regulations have been put into place to increase patient safety, reduce medical errors, and provide a foundation for secure global distribution of devices.
Today’s guest, Gary Saner, is an expert on UDI submissions and other regulatory topics. As the Senior Manager of Information Solution at Reed Tech, Gary is speaking to us today about the UDI submission procedures and other relevant topics.
“The UDI submission is not a one-time effort.” - Gary Saner
With over 30 years’ experience in software management and data conversion, Gary is the go-to person if you have questions about UDI, and his company can help medical device companies of any size be sure that their submissions are in order.
Some of the topics you’ll hear discussed on today’s podcast include:
- What UDI is and what information needs to be included in each of its components.
- The timeline of deadlines leading up to now and up to September 2016 as they pertain to different types of devices.
- Some of the challenges that apply to larger and smaller companies when it comes to meeting the 9/24/16 deadline, as well as how the Reed Tech tool can help organizations of all sizes.
- The importance of knowing and understanding the UDI submission process.
- The two submission methods that the FDA has in place.
- Tips and pointers to keep in mind as you go through the submission process.
Released:
Nov 7, 2019
Format:
Podcast episode
Titles in the series (100)
Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner: Standards are absolutely critical when you are developing a medical device. You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to i... by Global Medical Device Podcast powered by Greenlight Guru