DIMENSIONAL QUALITY CONTROL

For the Biomedical Sector

TEC Eurolab

TEC Eurolab

We perform all dimensional inspections to meet biomedical industry regulations

In an industry such as Biomedical, it is more crucial than ever to ensure the quality of the components and materials that will be marketed.

OUR DIMENSIONAL QUALITY CONTROL SERVICE IN THE BIOMEDICAL FIELD

  • Dimensional measurements with issuance of customized test report
  • Numerous printed control with precision and speed
  • Dimensional measurements of internal dimensions not achievable by high-resolution tomographic systems
  • Tomographic validation for dimensional measurements with OGP optical machine and Zeiss Prism CMM
  • Internal duct measurements and analysis by means of metrologically certified two-component material casts and subsequent dimensional evaluation with OGP optical machine
  • Measuring instrument analysis service

MSA (MEASUREMENT SYSTEMS ANALYSIS)

TEC Eurolab offers a service for analyzing measuring instruments according to procedures widespread in other important sectors (Automotive, Aerospace), which has long been practiced by major multinational companies in these sectors and is being rapidly developed in the Biomedical sector. This approach makes it possible to define with certainty whether the measurement system used is suitable for dimensional control of the dimensions under consideration and provides evidence of this with calculated parameters compared with reference values given in the standards.

  • Gage R&R
    • data collection and index calculation
    • measurement system suitability evaluation
    • method validation
    • Control procedure creation and control standardization
  • Support in metrology and programming of measurement systems

 

REFERENCE REGULATIONS FOR THE BIOMEDICAL SECTOR

ISO 13485
AQL UNI ISO 2859

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