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.
For more information, visit: ZEISS CMM Validation Services
Source: Carl Zeiss Industrial Quality Solutions, LLC
www.zeiss.com/newsroom
About ZEISS
ZEISS is an internationally leading technology enterprise operating in the fields of optics and optoelectronics. In the previous fiscal year, the ZEISS Group generated annual revenue totaling 8.8 billion euros in its four segments Semiconductor Manufacturing Technology, Industrial Quality & Research, Medical Technology and Consumer Markets (status: 30 September 2022).
For its customers, ZEISS develops, produces and distributes highly innovative solutions for industrial metrology and quality assurance, microscopy solutions for the life sciences and materials research, and medical technology solutions for diagnostics and treatment in ophthalmology and microsurgery. The name ZEISS is also synonymous with the world’s leading lithography optics, which are used by the chip industry to manufacture semiconductor components. There is global demand for trendsetting ZEISS brand products such as eyeglass lenses, camera lenses and binoculars.
With a portfolio aligned with future growth areas like digitalization, healthcare and Smart Production and a strong brand, ZEISS is shaping the future of technology and constantly advancing the world of optics and related fields with its solutions. The company’s significant, sustainable investments in research and development lay the foundation for the success and continued expansion of ZEISS’ technology and market leadership. ZEISS invests 13 percent of its revenue in research and development – this high level of expenditure has a long tradition at ZEISS and is also an investment in the future.
With over 38,000 employees, ZEISS is active globally in almost 50 countries with around 30 production sites, 60 sales and service companies and 27 research and development facilities (status: 30 September 2022). Founded in 1846 in Jena, the company is headquartered in Oberkochen, Germany. The Carl Zeiss Foundation, one of the largest foundations in Germany committed to the promotion of science, is the sole owner of the holding company, Carl Zeiss AG.
Further information at www.zeiss.com
ZEISS Industrial Quality Solutions
ZEISS Industrial Quality Solutions is a leading manufacturer of multidimensional metrology solutions. These include coordinate measuring machines, optical and multisensor systems, microscopy systems for industrial quality assurance as well as metrology software for the automotive, aircraft, mechanical engineering, plastics and medical technology industries. Innovative technologies such as 3D X-ray metrology for quality inspection round off the portfolio. In addition, ZEISS Industrial Quality Solutions offers a broad global spectrum of customer services with ZEISS Quality Excellence Centers close to its customers. The company is headquartered in Oberkochen. Production and development sites outside Germany are located in Minneapolis in the USA, Shanghai (China) and Bangalore (India). ZEISS Industrial Quality Solutions is part of the Industrial Quality & Research segment.
SOURCE Carl Zeiss Industrial Quality Solutions, LLC
