Customers can now purchase validation solutions for ZEISS Coordinate Measuring Machines (CMMs) from ZEISS. For quality assurance systems to be valid, they must meet the standards set by regulated industries. With the comprehensive spectrum of training and services offered by ZEISS Industrial Quality Solutions, customers may now reduce the time needed for the integration of their new quality assurance system.

Validation is a crucial part of the quality control process for medical devices. However, device manufacturers who are new to CMMs find it difficult to validate the software and systems, and they frequently are unsure about how to comply with FDA regulations. These companies frequently request from the CMM supplier FDA solutions and validation advice in order to fulfil industry requirements like 21 CFR Part 11 and 21 CFR 820.

ZEISS has developed guidelines and validation techniques to adhere to FDA criteria after considerable research. In order to validate its CMMs and the full inspection procedure, ZEISS is offering support. The medical sector has fought for a long time to get a clear understanding of how to validate CMMs, metrology software, part programmes, and the full inspection process. We’ve developed clear solutions that are in line with FDA requirements through our research and client feedback, says Scott Lowen, Medical Industry Solutions Leader and Software Product Manager for ZEISS Industrial Quality Solutions in the U.S.

Product and Service Offering

For manufacturers subject to FDA regulation, ZEISS offers a range of services, including a cost-free eLearning course and a complete, scalable solution. With the help of this service from ZEISS, validation in compliance with FDA regulations from 21 CFR Part 11 and Part 820 is supported and given full instructions.