I've been working on Vitrix Health (vitrixhealth.com) for about a year now and we are now looking into getting our manufacturing ready for scale. However, I was informed I need to be ISO 9001 and ISO 13485 compliant. (I know no experience in either of these two systems)
I downloaded the standards off the ISO website and am pretty lost on how to actually set up a compliant QMS system. I know there's some software out there but all of it seems rather cumbersome to set up if you do not know how to set up one already.
Does anyone have any resources for how to set up a solid QMS system?