For medical parts manufacturers, quality inspection is critical. Liability for defects, inconsistent quality, fluctuating supplier costs, increased globalization and device regulations all pose challenges for the industry.

The margin of error approaches zero for medical devices being brought to market. Medical manufacturers must be compliant with the FDA’s current good manufacturing practice (CGMP) requirements that assure proper design, monitoring and control of manufacturing processes and facilities.

With so much riding on achieving perfection, every step of the development process must be optimized for quality through repeatability, reproducibility and traceability.

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