Answers · Updated 2026-10-31
How do I quote medical device parts?
Price one of your own parts: Drop a STEP model or PDF drawing — about 90 seconds, no account.
Your part priced in about 90 seconds, no account.
Price the machining route plus material-lot traceability, cleaning, validation, inspection, packaging, and quality-agreement deliverables; do not claim medical certification you do not hold.
See how QuotedPart connects to your workflow with its API, MCP server, autonomous quoting and shop-specific learning.
The direct answer
A 100-piece 316L component may need $90 lot traceability, $160 cleaning and packaging, and an inspection report in addition to machining. Show which records are included.
Test the decision against the shop evidence in this example: A 100-piece 316L component may need $90 lot traceability, $160 cleaning and packaging, and an inspection report in addition to machining.
Carry the measurable input from the worked case into the estimator's notes: A 100-piece 316L component may need $90 lot traceability, $160 cleaning and packaging, and an inspection report in addition to machining.
Evidence from a shop floor
An illustrative 316L shaft route totals $506 direct for material, setup, turning, report, cleaning, and packaging; at 30% markup it is $657.80. Have quality review the customer agreement and processor approvals before issuing the firm quote.
Keep the commercial decision tied to the evidence, including a 100-piece 316l component may need $90 lot traceability, $160 cleaning and packaging, and an inspection report in addition to machining.
The handoff is complete only when the owner can restate the route without losing a 100-piece 316l component may need $90 lot traceability, $160 cleaning and packaging, and an inspection report in addition to machining.
Build the quote route
Identify intended use, quality agreement, material certificates, cleanliness, validation, inspection, packaging, and release records.
A useful review question is whether the current RFQ still matches this route: identify intended use, quality agreement, material certificates, cleanliness, validation, inspection, packaging, and release records.
The next estimator should be able to challenge the assumption behind this route: identify intended use, quality agreement, material certificates, cleanliness, validation, inspection, packaging, and release records.
Use the source notes to date the assumption and record why this route was selected: identify intended use, quality agreement, material certificates, cleanliness, validation, inspection, packaging, and release records.
Release and learn
Do not imply FDA approval or a quality certification from a customer requirement; confirm applicable scope.
If the buyer asks for a different outcome, explain the boundary in these terms: do not imply fda approval or a quality certification from a customer requirement; confirm applicable scope.
Before changing the total, verify whether the caveat applies: do not imply fda approval or a quality certification from a customer requirement; confirm applicable scope.
A customer-facing explanation should make the risk legible: do not imply fda approval or a quality certification from a customer requirement; confirm applicable scope.
Close the loop by noting the evidence that would make this estimate obsolete: do not imply fda approval or a quality certification from a customer requirement; confirm applicable scope.
Keep the commercial decision tied to the evidence, including a 100-piece 316l component may need $90 lot traceability, $160 cleaning and packaging, and an inspection report in addition to machining.
Price one of your own parts
Drop a PDF drawing or a STEP file. QuotedPart reads the print, measures the model and prices it in seconds, on default shop rates you can change.
Your STEP file or PDF drawingDrop a PDF drawing, a STEP file or both
Free. No account, no email. Priced at our default US rates until you set yours.
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Can I ship 10% more or fewer parts than ordered?
Only when the purchase order or customer has agreed a quantity tolerance; there is no universal right to ship ten percent extra or short.
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Can I use Xometry or Protolabs instant quotes as a price check?
Use an instant quote as a dated comparison point after matching quantity, revision, finish, inspection, freight, and delivery scope; it is not a neutral market index.
Answers
Customer sent a STEP file but no drawing — what tolerance do I quote?
Use a written model-only default only when the customer accepts it; a practical example is to model with ±0.005 inch unless a drawing states otherwise, while calling out material, finish, threads, and inspection as open.
Answers
Customers make us re-enter quotes in their supplier portals — how do other shops handle it?
Treat portal re-entry as measurable quote administration: export the approved quote, time the work, and decide whether the effort is included or charged.