We're a small team building our first medical device and drowning in design control requirements (21 CFR 820.30). The big-company templates don't fit us. For those who've done this lean: what was your minimum viable QMS, and what do you wish you'd set up earlier?

Design controls can feel overwhelming for a small team, but starting with the intended use and user needs usually keeps things grounded. From there, it is a matter of linking requirements to verification and validation, then keeping the documentation tight enough to survive scrutiny later. Material selection tends to come up early too, and choosing reliable Cardiovascular Device Materials from the outset saves considerable rework down the line. Thanks for raising this.