Does every complaint need a full investigation?

No. Every complaint is reviewed and evaluated, but section 820.35(a) needs no new investigation when a similar complaint was already investigated, provided you record the justification. Each reportable event still needs its own investigation under section 803.50.

Which hours cover the medical device report decision?

The evaluation hours: deciding whether a complaint meets the Part 803 reporting criteria is part of evaluating it. Add report preparation to the investigation hours of reportable complaints; most reports are due within 30 calendar days, five work days when a remedial action is needed.

Why did cost per complaint rise when complaints fell?

Because the complaint system cost is fixed per period, fewer complaints each carry more of it, and a new failure mode raises the share you investigate. Compare the share investigated and investigation hours before judging cost per complaint.

What belongs in the complaint system cost?

The period's share of the complaint database or eQMS license, hosting and software validation, plus trending reports you buy. Keep staff time out: evaluation and investigation hours already price the people.

MedTech Manufacturing calculator

Complaint Handling Cost Calculator

Find what your complaint process costs per period and per complaint before you set next year's budget or build an eQMS business case. You need complaint counts, hours per complaint, a burdened rate and system cost.

What this calculator does

Period and per-complaint cost of evaluating every complaint, investigating those that need it, and running your complaint system.

Formula used

Evaluation cost = complaints received × evaluation hours per complaint × burdened hourly rate
Investigation cost = complaints investigated × investigation hours per complaint × burdened hourly rate
Complaint handling cost = evaluation cost + investigation cost + complaint system cost
Cost per complaint = complaint handling cost ÷ complaints received
Share investigated = complaints investigated ÷ complaints received

Inputs explained

Complaints Received per Period: New complaint files opened in the period, from your complaint log.
Evaluation Hours per Complaint: Intake, follow-up, reportability decision and closure, for every complaint.
Complaints Investigated: Complaints given a full investigation; the rest cite a similar earlier one.
Investigation Hours per Complaint: Returned-device failure analysis, device history record review and root cause.
Burdened Hourly Rate: Blended wage, benefits and overhead of complaint and quality staff.
Complaint System Cost per Period: Complaint database or eQMS license, hosting and validation share; no staff time.

How to use the result

Best suited to budgeting complaint unit hours for next year, building an eQMS complaint module business case, costing a complaint spike after a launch.
Excludes corrective actions, recalls and replacement product that complaints trigger; price those separately.

Current U.S. benchmarks

U.S. manufacturing runs at 75.7% of capacity with new factory orders at $663B per month (Federal Reserve and Census, Aug 2026).
The U.S. has 8,825 medical equipment and supplies establishments employing about 308,388 workers (Census County Business Patterns, 2023).

Common questions

Does every complaint need a full investigation? No. Every complaint is reviewed and evaluated, but section 820.35(a) needs no new investigation when a similar complaint was already investigated, provided you record the justification. Each reportable event still needs its own investigation under section 803.50.
Which hours cover the medical device report decision? The evaluation hours: deciding whether a complaint meets the Part 803 reporting criteria is part of evaluating it. Add report preparation to the investigation hours of reportable complaints; most reports are due within 30 calendar days, five work days when a remedial action is needed.
Why did cost per complaint rise when complaints fell? Because the complaint system cost is fixed per period, fewer complaints each carry more of it, and a new failure mode raises the share you investigate. Compare the share investigated and investigation hours before judging cost per complaint.
What belongs in the complaint system cost? The period's share of the complaint database or eQMS license, hosting and software validation, plus trending reports you buy. Keep staff time out: evaluation and investigation hours already price the people.

Last reviewed 2026-10-01.