NOTE Basildon has achieved ISO13485:2016 certification for its Medical Device and Quality Management System. The 2024 certification, awarded by LRQA Limited after a successful audit, highlights NOTE UK’s commitment to quality in medical device manufacturing.
The ISO13485:2016 certification is a significant endorsement. It indicates that NOTE’s quality management system (QMS) meets stringent regulatory requirements specific to the medical device industry. This milestone ensures that NOTE UK will adhere to high standards in the development and manufacturing of medical products.
Neil Owen, NOTE UK Group Managing Director said, “I am proud of this achievement which emphasises our team’s dedication to meeting both customer and international regulatory expectations for the manufacture of medical devices. The ISO13485:2016 standard is a globally recognised benchmark for quality systems in medical device development and manufacturing. This certification underscores NOTE UK’s rigorous and risk-based approach to developing and commercialising innovative medical devices for our customers.”