Rev.1 Engineering Receives ISO 13485:2016 Certification
TEMECULA, Calif., Sept. 25, 2023 /PRNewswire/ -- Rev.1 Engineering, a medical device design and development company, announced that they received the ISO 13485:2016 certification for its quality management system. This certification indicates Rev.1's robust policies and procedures for the development and manufacturing of medical devices.
ISO 13485:2016 serves as an industry benchmark for Quality Management Systems, offering a structured framework that aligns medical device design, development, and production with precise customer requirements and stringent regulatory demands.
"Acquiring the ISO 13485:2016 certification is a significant accomplishment for Rev.1 Engineering that fully demonstrates our commitment to product quality and regulatory compliance," said Laura Herrera, the Vice President of Quality at Rev.1 Engineering.
"Coupled with our in-house expertise in medical device development and manufacturing, our certification will assure our customers of our suitability as their best choice as a contracted partner for their product development and strategic manufacturing needs."
With the ISO 13485:2016 certification, Rev.1 Engineering is better able to support their customer's needs with the most current regulatory requirements specific to the medical device industry.
About Rev.1 Engineering
Headquartered in Southern California, Rev.1 Engineering is a medical device design and development firm that has been serving innovative MedTech businesses since 2007. Their services range from concept ideation and prototype development to Early Manufacturing and beyond. Visit https://www.rev1engineering.com for more information.
An ISO 13485:2016 certification indicates a company's quality management system meets the most current regulatory requirements for the medical device industry.
SOURCE Rev.1 Engineering
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