[Joe]

Hey Holly – Good morning,

Yeah, great question! A lot of it will be language-based changes, however there are a few additional things we are adding: 1. QMSR incorporates UDI directly into its core requirements, specifying that UDI information must be recorded for each device or batch in records like complaint investigation records and service histories, as applicable (traceability and record control). 2. We are moving to an eQMS system as a paper-based QMS (at least for us) has not allowed records to be easily or readily available for and during inspections.

Hope this helps!

Joe