LAB READY
1
Define what a successful fit means
The RFQ should identify mating parts, critical interfaces, movement or engagement expectations and any customer-supplied components required for the check.
Lab-Ready Delivery
Prototype assembly and fit testing before delivery
Check how mating components come together before shipment so a dimensional issue, interface conflict or missing operation is found earlier.
Capability Overview
Assembly & Fit Testing built around the application
Individual parts can meet their drawings and still reveal an interface problem when the assembly comes together. Optional fit testing and trial assembly give the team another checkpoint before shipment. The scope is established during quoting and may cover supplied mating components, multi-part prototype sets or basic functionality checks appropriate to the build.
OptionalFit and function scope defined per RFQ
Before shipmentFind interface issues earlier
Multi-partTrial assembly for mating components
Documented scopeRequirements agreed before work starts
Planning the Work
What matters before manufacturing starts
Process selection should follow the drawing, application, material, critical features and the condition in which the part needs to arrive.
2
Coordinate the whole part set
Machining, printing and finishing can be planned around the final assembly condition instead of treating every component as an isolated delivery.
3
Keep evaluation separate from device validation
Fit checks confirm the agreed prototype assembly scope; formal verification, validation and regulatory acceptance remain the device manufacturer’s responsibility.
Typical Applications
Where this capability fits
Implant-to-instrument interfaces
Multi-part surgical instruments
Prototype construct assemblies
Housing and insert fit
Development jigs and fixtures
Revision-to-revision comparison
Related Guidance
Continue planning the part
Use these pages to connect the process with the device category, material and next project decision.
Frequently Asked Questions
Assembly & Fit Testing questions
What can be included in a fit check?
The agreed scope can cover mating components, trial assembly and basic functionality checks appropriate to the prototype build.
Can customer-supplied mating parts be considered?
Yes, when they are identified during quoting and suitable arrangements are made for the required components and acceptance criteria.
Does a prototype fit check replace formal device validation?
No. It is a manufacturing and assembly checkpoint; formal verification, validation and regulatory decisions remain with the device manufacturer.
Have a part ready to review?
Send the CAD, quantity, material, finish and target date for a process review and quote.