Hi Everyone

In case you missed the live webinar, the recording is still available on demand:

https://get.instem.com/global-udi-webinar/

Within each regional UDI system (Unique Device Identification), manufacturers are legally obliged to identify and register their medical devices. It all instances, this is not just about receiving a single UDI code, and recording what was submitted and to which authority, but requires the collection, management and submission of perhaps a hundred odd data elements in addition to the UDI code. A fact often overlooked and underappreciated. 

Meeting these complicated and variable needs for each health authority’s “unique” device identification requirement in a global environment is an arduous task. UDI data compliance adds an additional layer of complexity to an already resource stretched team. Managing the regulatory data across regions, languages, timezones and facilities without a robust and efficient process is not sustainable. Non-compliance is not an option. 

As always, please free to contact me with blog comments or suggestions for future post topics. I appreciate all feedback 🙂

kimyoung@instem.com

K Young

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