Accurate measurement of components used to manufacture medical devices is critical in ensuring the function and compliance of the device. To meet increased demand in inspection activities, Europlaz has expanded its metrology capability. This is with the purchase of a fully automatic Coordinate Measuring Machine (CMM). The CMM complements the two existing machines used by the company.
The machine offers full three-dimensional inspection through both touch and vision sensors. This enables us to make complex measurement quickly and easily.
Medical Device Regulation
The regulations for medical devices require that where a device cannot be verified, for example where it is single-use, the process of manufacturing must be verified.
The industry-standard approach to validation is through dimensional measurement of the component and through the use of the Ppk & Cpk formulas. These formulas indicate if a process is stable or not and are highly susceptible to measurement error.
Europlaz’s new Coordinate Measuring Machine measures with an accuracy down to 3 microns, or about 25 times smaller than the diameter of a human hair. This level of accuracy all but eliminates measurement error, meaning that the Ppk & Cpk are completely represented of the manufacturing process and that the process used to manufacture customers products is completely ensured.
Finally, the new equipment is capable of producing full ISIR and Capability reports with its built-in software.
Metrology services are provided by experienced staff using calibrated equipment traceable to NIST standards:
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- Programmable Contact/Non-Contact Measurements
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- Metrology Analysis and Reports
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- Capability Studies
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- Gage R&R
- FAI’s
Coordinate Measuring Machine Staff Training
Complementing the purchase of this machine, our inspection staff have undergone training with the National Physics Laboratory. The training is in best practice measurement and staff have brought these skills back to their day to day work.
For further information on our services please call us on 01621 773471 or complete our contact form.
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