Understands why device regulation centres on design controls and post-market surveillance rather than batch conformity — the product is used rather than consumed, and the user is part of the system.

WHAT IT LOOKS LIKE · 5

• Keeps design inputs, outputs, verification and validation traceable, so an unverified input is visible rather than assumed.
• Distinguishes verification — the device meets its specification — from validation — the device meets the user’s need in use.
• Carries risk management through the whole lifecycle, updating it from production and post-market information rather than closing it at launch.
• Judges a complaint for reportability on its own facts and within its timeline, instead of waiting for the investigation to conclude.
• Feeds post-market findings back into design and risk, so the field experience changes the product rather than only the file.

HOW IT IS DEMONSTRATED AT WORK

Trace one requirement from user need to validation evidence and back, and look for a design review with a recorded decision that changed something. In the post-market half, look for a reportability decision made and documented on time — including a decision not to report, with its reasoning — and for at least one complaint whose analysis reached the risk file.

WHERE IT IS COMMONLY WEAK

The weak seam is between design and post-market: the risk file is completed for approval and then frozen while the field tells a different story. Complaint handling fails in a specific way — the reportability decision waits for the investigation, which is backwards, because the clock runs on the information available and the investigation can refine it later. Software devices add a third: a change managed as maintenance that alters what the device does.

WHAT TEACHES IT · 1

• CAREER PATHWAYMedical Device Quality — career pathway

WHAT EXERCISES IT · 0

Nothing exercises this yet. 10 scenarios are published and none is linked to this entry — we would rather say so than point you at the closest one.