LAB READY
01
Control the requirement
Identify the drawing revision, material, quantity, finish and critical features so the quoted route reflects the actual requirement.
Quality Management
Quality planned around the part and its purpose
ISO 13485-certified quality management for orthopedic prototype and low-volume manufacturing work.
What Certification Means
A quality system for medical-device manufacturing work
Lab Ready states that it is ISO 13485 certified. ISO 13485 is a quality-management-system standard specific to medical devices; it addresses how an organization controls its processes and records rather than certifying that every individual component automatically meets its drawing.
Part acceptance still begins with the actual RFQ: drawing revision, material, critical dimensions, surface condition, inspection expectations and any documentation the customer requires. Those requirements should be agreed before manufacturing begins.
Quality Planning
Define acceptance before the part is made
The right level of control depends on the component, development stage and what the customer needs to prove.
02
Plan inspection
Call out dimensions, interfaces or surface requirements that need documented inspection instead of assuming every feature needs the same level of reporting.
03
Confirm documentation
Ask for applicable material, process or inspection records during quoting so availability and delivery requirements are clear before production.
Include With the RFQ
Quality information that prevents ambiguity
Drawing and revisionThe controlled geometry and current revision level.
Critical featuresDimensions and interfaces that determine fit or function.
Material and conditionGrade, condition and any applicable certificate requirement.
Surface specificationFinish, coating, masking and cosmetic requirements.
Inspection deliverablesMeasurements or reports required with shipment.
Fit-check scopeMating components and agreed evaluation criteria.
Important Distinction
Prototype manufacturing support is not device approval
Lab Ready manufactures parts to the agreed project requirements. The device manufacturer remains responsible for design controls, verification and validation, regulatory strategy, supplier qualification and determining whether a component is suitable for its intended use.
Have specific quality requirements?
Include inspection, documentation and critical-feature requirements with the RFQ so they can be reviewed before work starts.