Bally Ribbon Mills (BRM), which designs, develops and manufactures highly specialized engineered woven fabrics, announces that the company has received ISO 13485:2016 certification, the international standard that governs the design and manufacture of medical devices. BRM passed a surveillance audit with zero non-conformances.
For more than 50 years, BRM has been supplying high quality medical products to its customers. BRM has met this standard for medical devices by focusing on risk management and design control during product development and by manufacturing its products in a controlled work environment. In addition, BRM follows specific requirements for inspection and traceability for implantable devices as well as for verification of the effectiveness of corrective and preventive actions.
BRM’s facility includes advanced weaving systems, yarn preparation, and inspection areas for the production of fabric to stringent requirements. Environmental sampling, data collection, storage and alarms ensure complete environmental monitoring and redundancies. Quality efforts also include an emphasis on continuous improvement and defect prevention.