Change impact analysis is the silent time-sink in every medtech QMS

I recently sat through a design-change review where a single component change — a different connector supplier for a cardiac monitor cable — ballooned into requests for updates across what felt like the entire Technical File. Counted them up afterwards: fourteen distinct documents and artefacts touched. Nobody had mapped that up-front. The auditor did, of course, during the next surveillance audit. This is common. The technical theory is clear: MDR requires up-to-date technical documentation (An