QA vs. RA - The difference between QA and RA

[tazer]

I post my question here because it become our favorite pastime during coffee breaks. It concerns the difference between QA and RA.
Having often worked in small medical device structures where only one person occupies 2 functions QA / RA.
Do you have an opinion on

 

[Marc]

An opinion on what?

 

[Jen Kirley]

And can you also tell us what QA and RA are? I can suspect what you refer to as QA, but the other I am not sure about.

 

[tazer]

I wanted to talk about the role and responsibilities of the Quality Assurance and Regulatory Affaire services

 

[Marc]

I wanted to talk about the role and responsibilities of the Quality Assurance and Regulatory Affaire services

I can see you're trying to imbed a link to a graphic, (apparently using a Mozilla extension of some sort) but it doesn't show.

You might have to copy the image to your computer desktop and upload it from there.

https://elsmar.com/elsmarqualityforum/moz-extension://a81d5c1b-abef-4314-86e7-10041ab8eeb6/informenter-marker-1.png

 

[tazer]

I can see you're trying to imbed a link to a graphic,

No I don't

 

[Ronen E]

In medical devices there’s a big overlap between QA and RA. In most advanced systems (say, EU and USA for example) QA is a subset of RA in my opinion, because the regulations not only require high quality (and thus all the QA activity), they’re also quite prescriptive in how to go about it. Then, RA has some aspects which don’t come strictly under QA (eg registration). There might be a few exceptions (aspects of QA which are outside RA) depending on how you define Quality and QA, though.