UDI and Product Data
This page provides blogs, short videos and recordings focused on industry insights for regulatory requirements and best practices to manage medical device product data for established and newly formed Health Authority UDI mandates around the world.
Recent Blogs
Preparing, Managing and Monitoring Medical Device UDI
In today’s ‘Coffee Talk’ we are chatting with Linda Morehouse, Account Executive with Reed Tech Life Sciences. Linda...
How Can You Prepare for Unique Device Identification Product Data Submission in Asia?
Reed Tech subject matter experts, Gary Saner, Information Solutions Senior Manager and Patti Shragher, Medical Device...
How Does Software as a Medical Device Relate to Unique Device Identification?
Determining Software as a Medical DeviceIt is critical to first determine if the software article is a Device...
Is My Product a Medical Device?
A frequent question on medical devices concerns determining ‘if’ a product is defined by US FDA as a ‘medical device’....
What is a UDI label and UDI requirements?
What is UDI?Unique Device Identification is a globally unique, unambiguous identification comprised of a Device...
Medical Device Classifications in Global Markets and Health Authorities
When marketing medical devices around the globe, manufacturers face the significant challenge of meeting requirements...
FDA GUDID Class I Reminder
(This blog was updated July 22, 2022) What is the Global Unique Device Identification Database, also known as GUDID?...
EU’s Requirement for Implant Cards Provides Key Information for Patients
The European Union (EU) requires manufacturers to supply ‘implant cards’ for patients with implanted medical devices,...
Updated Survey Shows Most Are Continuing Preparation for EU EUDAMED
Polls conducted May 20, 2021 Survey ResultsAre you as a medical device manufacturer, in the middle of preparing for...