ZEISS CMM Validation Service

Accelerate your quality assurance validation process

Validation is a required aspect of medical device quality assurance and is essential for complying with FDA requirements. A clear understanding of regulations, well-defined URS and IQ/OQ plans, and guidance from the CMM and metrology software provider are crucial for a successful validation process by medical device manufacturers.

Backed by extensive research, ZEISS Industrial Quality Solutions has established guidelines and validation methods to ensure compliance with FDA standards, including the criteria outlined in 21 CFR Part 11 and 21 CFR Part 820. ZEISS offers a comprehensive range of services designed to support the FDA validation of ZEISS CMMs and the entire inspection process.

CMM and inspection process services

Introduction to validating CMM systems for FDA compliance

Free 1 hour eLearning

An introduction to best practices and methods used in the regulated industry to validate CMM systems and the CMM inspection process to meet 21 CFR Part 11 and 21 CFR 820 regulations. Course objectives include:

Describe common challenges associated with the validation of CMM systems and metrology software used for medical device manufacturing.
Define the key terms and divisions of a Double-V model of validation, including URS, FRS, TRS, Implementation, IQ/OQ/PQ, and CMM System vs. Inspection Process.
Accurately characterize the relevance of each requirement outlined in 21 CFR Part 11 and Part 820, emphasizing their significance in the validation process.

CMM validation solution for FDA compliance

Tailored protocols, remote support, and online Training

Introducing a comprehensive solution for FDA-regulated manufacturers seeking to validate CMM systems and the inspection process. In partnership with ZEISS, receive detailed guidance and support for meeting FDA requirements outlined in 21 CFR Part 11 and Part 820. Key features include:

Customized validation protocols developed collaboratively to align with the specific needs of medical device manufacturers.
Direct remote support to implement defined technical requirements, ensuring a smooth and efficient validation process.
Remote assistance during the qualification process of the CMM system, covering Installation Qualification (IQ) and Operational Qualification (OQ).
Access and implement industry-accepted guidelines for validating inspection processes, guaranteeing alignment with regulatory standards.
Live online training on methods of validation and use of documents (6 to 8 hours recommended).

ZEISS guides manufacturers to FDA validation of coordinate measuring machines

Fill out the form to download our whitepaper to understand industry standards, identify challenges in validation and find best solutions.

Whitepaper

Understand industry standards
Identify challenges in validation
Find best solutions

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ZEISS CMM Validation Service

Accelerate your quality assurance validation process

CMM and inspection process services​

Introduction to validating CMM systems for FDA compliance​

Free 1 hour eLearning​

CMM validation solution for FDA compliance​