October 30, 2024
Reinforcing Commitment to Medical Device Quality and Compliance.
Norman Noble, a global leader in the contract manufacturing of advanced medical implants and devices, announces the successful renewal of its Quality Management System (QMS) certification to the ISO 13485:2016 standard. This milestone comes after an extensive and thorough audit conducted by the British Standards Institute (BSI), a prestigious European Union Notified Body.
ISO 13485:2016 is an internationally esteemed quality standard specifically designed for the medical device sector. By securing this recertification, Norman Noble reaffirms its steadfast commitment to upholding the highest standards of product quality and regulatory compliance in the medical device industry. The company has maintained ISO 13485 certification since 2004, consistently demonstrating a proactive approach to meeting evolving regulatory requirements on both domestic and global fronts, including those set by the FDA, European MDR, and Brazil ANVISA.
This achievement not only fortifies Norman Noble’s reputation as a trusted partner in the medical device manufacturing industry but also provides crucial support to its customers in navigating the complex regulatory landscape.
Click here to download a PDF of this ISO 13485 Certification Press Release.