[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

[Joe]

Hey Michelle – Good morning,

I’m with a startup company now, and I’ve organized a quality plan to phase out the much of the QSR lingo to align with ISO 13485:2016/QMSR terminology. Aside from the language, other aspects of my quality plan involve a review of other core processes, such as complaint handling, medical device reporting (i.e. Parts 803/806), document/record control (Part 11), risk management, & training. I’m not anticipating too much legwork as we are already ISO 13485-certified.

Hope this helps!

Joe