Validation is a required component of medical device quality assurance. But device manufactures new to CMMs find it challenging to validate the software and systems, and they aren't always sure how to achieve FDA compliance. These businesses often ask the CMM supplier to provide FDA solutions and validation guidance to meet the industry standards, including, 21 CFR Part 11 and 21 CFR 820.

Through extensive research, ZEISS has established guidelines and validation methods to comply with FDA standards. ZEISS is providing support to validate ZEISS CMMs and the entire inspection process. "For many years the medical industry has debated and struggled with clear direction on how to validate CMMs, the metrology software, the part programs and the entire inspection process. Through our research and with customer feedback, we've defined clear solutions that are aligned with the FDA regulations," states Scott Lowen, Medical Industry Solutions Leader, and Software Product Manger for ZEISS Industrial Quality Solutions in the U.S.

Service Product Offering
ZEISS offers a variety of services from a free eLearning course to a comprehensive, scalable solution for FDA-regulated manufacturers to validate their CMM systems and inspection process. This service from ZEISS provides detailed instructions and support for validation in accordance with FDA regulatory requirements from 21 CFR Part 11 and Part 820.