ZEISS Insights: Technical paper GD&T and final assembly inspection of medical devices

Medical plastics deliver a pharmaceutical compound to its target site. Given their direct impact on quality of life, they are subject to a variety of strict quality assurance regulations including FDA 21 CFR Part 11. Measurement speed is also vital for efficient handling of the huge quantities of medical plastics that are produced. From geometric dimensioning and tolerancing to final inspection of the assembly, the key to effective quality assurance is ensuring seamless interaction between hardware and software – and ZEISS has developed a number of innovations in recent years. Operators can perform single-point measurements, full 3D tactile continuous scanning, and optical measurements with the ZEISS O-INSPECT multisensor measuring machine and the latest ZEISS CALYPSO software options. The ZEISS METROTOM 1 computed tomography system and Volume Inspect Pro software provide all-round quality analysis. Though these are very different processes, they are united by ZEISS’ innovative drive and regulatory focus that can help overcome all operational hurdles.