SPOT Radio

UDI (Unique Device Identification) is your company compliant? Part 1

January 08, 2021 Charlie Webb, Ryan Erickson, Ryan Ott Season 3 Episode 1
SPOT Radio
UDI (Unique Device Identification) is your company compliant? Part 1
Show Notes

Podcast Episode Description:

 

On this episode of SPOT radio, Charlie Webb speaks with Ryan Erickson and Ryan Ott of Packaging Compliance labs about the needed step to conform to the UDI (Unique Device Identification) printing requirements. Also discover how SMEs can provide a valuable link to conform to the heightened expectations of the new regulatory girth of the ISO-11607-2019 and the UDI (unique device identifier) printing directive.


Guest Description:


Ryan Erickson is a co-founder and Vice President of Packaging Compliance labs; he serves as the technical expert on the team, guides trainings, and runs lean events. Erickson formed PCL with partner Matthew Lapham with the mission to help medical device and pharma clients speed their products to market by breaking down the barriers that relate to packaging. 


Ryan has 12 years’ experience in medical device packaging engineering, beginning as a Packaging Engineer at Cardinal Health in Chicago. At Cardinal Health, Ryan served as a packaging engineer as he developed his skills in packaging validation and testing. Upon returning to his hometown of Grand Rapids, Erickson became the Packaging Engineering Manager for Vention Medical, a large contract manufacturer.


Contact:


Website: https://pkgcompliance.com

e-mail: rerickson@pkgcompliance.com


Ryan Ott is the Director of Quality and Principal Packaging Engineer at Packaging Compliance Labs; he is PCL’s resource for all things quality related including, but not limited to, executing supplier agreements, answering questions about test standards, and scheduling audits.

Ott earned a degree in Packaging at Michigan State University and began his career in Packaging at Vention Medical. In 2016, Ott joined Packaging Compliance Labs as a Senior Packaging Engineer.

Website: https://pkgcompliance.com

e-mail: rott@pkgcompliance.com

UDI Links for reference:
Here’s the Primary GS1 site (You can go to the U.S. or Global sites from here):

 https://www.gs1.org/
Download the GS1 General Specifications Guide here:

https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specific…
FDA website for UDI:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-…