[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