anyone else struggling with design reviews in regulated work?
we're a mid size med device team combination product type of company. we mostly got the requirements side under control at this point. its the design review and approval cycle that keeps getting chaotic.
right now we export stuff to Word, mark it up in a review meeting or over email, then one person has to merge everything back into the tool. by the time the review closes the requirements have sometimes changed, so keeping the review record tied to the right version gets harder than it should be.
we've got a 510(k) coming up so the design reviews cant just be a rubber stamp. they need to hold up if an auditor starts pulling threads. trying to figure out how other regulated teams handle this. is the review process built into your requirements management software or are people still stitching it together with Word and email?