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Bally Ribbon Mills (BRM, Bally, PA, US), manufacturer of specialized engineered woven fabrics, has received ISO 13485:2016 certification. ISO 13485 is the international standard that governs the design and manufacture of medical devices. BRM passed a surveillance audit with zero non-conformances.

The company says it meets the ISO 13485 standards for medical devices by focusing on risk management and design control during product development and by manufacturing its products in a controlled work environment. BRM says it 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. 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. Tools include Management and Feasibility Reviews, AS9102 First Articles, FMEA’s, Control Plans, IQ-OQ-PQ’s, Process/Product Validation and Lean/Six Sigma best practices.