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Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.
TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.
Some of the highlights of this episode include:“Every part that you use in the hospital room has a barcode on it.”
“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.”
“Nobody's really standardized."
“You can scan it to make sure that you are using the right product with the right other products and with the right patient.”
Links:Mark Rutkiewicz on LinkedIn
Mark Rutkiewicz on Twitter
Innovize
Consiliso LLC
Medical Device Company In A Box: The Case For Consiliso
FDA - Unique Device Identification System (UDI System)
European Union Medical Device Regulation (EU MDR)
Medical Device Innovation Consortium (MDIC)
ISO 13485 - Medical Devices
Greenlight Guru Academy
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
Greenlight Guru
4.8
9292 ratings
Do you understand how the Unique Device Identification (UDI) system in the medical device industry works? The overall concept can be best understood by learning how it is used and why it exists.
TIn this episode of the Global Medical Device Podcast, Jon Speer and Etienne Nichols talk to Mark Rutkiewicz, VP of Quality at Innovize, Founder of Consiliso LLC, and author of Medical Device Company In A Box. Listen to Jon, Etienne, and Mark discuss key points every medical device professional should know about the UDI system.
Some of the highlights of this episode include:“Every part that you use in the hospital room has a barcode on it.”
“If this patient was prescribed something, then you scan everything that they do. If somebody made a mistake, they would catch it right away.”
“Nobody's really standardized."
“You can scan it to make sure that you are using the right product with the right other products and with the right patient.”
Links:Mark Rutkiewicz on LinkedIn
Mark Rutkiewicz on Twitter
Innovize
Consiliso LLC
Medical Device Company In A Box: The Case For Consiliso
FDA - Unique Device Identification System (UDI System)
European Union Medical Device Regulation (EU MDR)
Medical Device Innovation Consortium (MDIC)
ISO 13485 - Medical Devices
Greenlight Guru Academy
The Greenlight Guru True Quality Virtual Summit
MedTech True Quality Stories Podcast
Greenlight Guru YouTube Channel
Greenlight Guru
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