Ming, I have not taken a combination product through a health authority inspection, so treat this as an auditor view of where these systems usually come apart rather than inspection experience. The weak point is nearly always the interface rather than either system on its own. Complaints, adverse events and device deficiencies arrive through different doors in a pharmaceutical QMS, and unless one person owns the decision on how each incoming signal is classified and routed, the device side of post market surveillance quietly sees only a filtered subset. If I were auditing you I would take real complaints from the pharmaceutical intake and follow them through to whether the device risk file was actually reviewed.
The second thing I would look for is evidence that post market data changed something, which is the practical version of the ISO 14971 point Frank raised. A trend review that concludes acceptable every quarter in the same wording tells an assessor very little, whereas one clear instance of a post market signal reopening the risk assessment and driving a design or labelling change is worth more than a shelf of procedures.
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Dilawar Laghari
Auditor, Consultant and Trainer
Audit Workshop
https://auditworkshop.com/------------------------------