Independent · source-linked · manufacturing-first
A measurement result is useful only when the method, feature definition, uncertainty, environment and acceptance rule make it fit for the decision being made.
Plan from function and risk
The drawing and specification define requirements; the control plan decides how and when to evaluate them. Critical interfaces may need multiple forms of evidence, while a low-risk feature may be controlled by a simpler gauge or process check.
Match equipment to geometry
CMM probing, vision, laser scanning, form measurement, surface instruments and CT each see different things. Accessibility, reflectivity, feature size, edge definition, material and required uncertainty affect method choice.
Validate the method
A calibrated instrument is not automatically a validated measurement process. Fixturing, software strategy, operator technique, sampling, environment and data handling can influence the result. Repeatability and reproducibility studies can help establish fitness for use.
Keep the record interpretable
The result should connect to the part, lot, revision, program or method revision, equipment status and disposition. Screenshots without context and exported point clouds without an acceptance decision are not complete device-history evidence.
Move from research to the machine
Use the manufacturing context here, then compare machine platforms, values and supporting technology inside Machine Blue Book.
Continue the medical manufacturing map
Primary sources and verification
Official sources control current regulatory, product and company facts. MBB last checked these links on September 28, 2026.
Independent educational reference: Machine Blue Book is not affiliated with Arthrex, FDA, ISO or any manufacturer named on this page. Names are used descriptively and linked to primary sources. This material is not medical, legal, regulatory or clinical advice and does not recommend a device for patient care.