Does every new medical device supplier need an on-site audit?

No. FDA's Part 820 now incorporates ISO 13485, whose clause 7.4 scales supplier evaluation to the part's effect on device quality and its risk. Where an audit is not practical, FDA allows historical data, trending, and inspection and testing.

Is the supplier's ISO 13485 certificate enough to approve them?

Not on its own. FDA notes that certification may not give adequate assurance of supplier quality without further evaluation, so pair it with first article results and a quality agreement.

What belongs in first article and test hours?

Your team's time proving the first parts meet the drawing and specification: dimensional layout, material certificate review, functional tests and the report. Outside lab fees go in travel and outside test spend.

How do I justify a second source with no price saving?

On supply risk, not payback. Enter zero saving, and the payback row stays blank. Then compare the qualification cost with what a shortage from your only source would cost in lost shipments.

MedTech Manufacturing calculator

Supplier Qualification Cost Calculator

Find what qualifying a supplier costs before you switch or add a source, and how fast the price saving repays it. You need audit, first article and agreement hours, a burdened rate, travel and test spend, and the saving.

What this calculator does

What qualifying a supplier costs in audit, first article and agreement hours plus travel and tests, and its payback.

Formula used

Internal hours = audit hours + first article and test hours + quality agreement and records hours
Labor cost of each activity = its hours × burdened hourly rate
Supplier qualification cost = internal hours × burdened hourly rate + travel and outside test spend
Payback period (months) = supplier qualification cost ÷ price saving per year × 12

Inputs explained

Audit Hours: Prep, on-site and report hours, summed over every auditor.
First Article and Test Hours: Dimensional layout, material certificate review and functional tests on first articles.
Quality Agreement and Records Hours: Quality agreement, approved supplier list entry and incoming inspection plan.
Burdened Hourly Rate: Blended wage, benefits and overhead of the supplier quality team.
Travel and Outside Test Spend: Airfare, hotel, outside lab fees and first article parts bought.
Price Saving per Year: Unit price saving times units bought per year; zero if none.

How to use the result

Best suited to budgeting a new component supplier, adding a second source for a critical part, checking a cheaper quote against its qualification cost.
One-time cost only: periodic re-audits, incoming inspection and scorecard monitoring after approval are not included. Excludes process validation and any regulatory filing the supplier change triggers.

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 new medical device supplier need an on-site audit? No. FDA's Part 820 now incorporates ISO 13485, whose clause 7.4 scales supplier evaluation to the part's effect on device quality and its risk. Where an audit is not practical, FDA allows historical data, trending, and inspection and testing.
Is the supplier's ISO 13485 certificate enough to approve them? Not on its own. FDA notes that certification may not give adequate assurance of supplier quality without further evaluation, so pair it with first article results and a quality agreement.
What belongs in first article and test hours? Your team's time proving the first parts meet the drawing and specification: dimensional layout, material certificate review, functional tests and the report. Outside lab fees go in travel and outside test spend.
How do I justify a second source with no price saving? On supply risk, not payback. Enter zero saving, and the payback row stays blank. Then compare the qualification cost with what a shortage from your only source would cost in lost shipments.

Last reviewed 2026-10-01.