BALLY, Pa. — February 21, 2019 — Bally Ribbon Mills (BRM) has announced the company received ISO 13485:2016 certification. ISO 13485 is the rigorous international standard that governs the design and manufacture of medical devices. BRM passed a surveillance audit with zero non-conformances.
For over 50 years, BRM has been supplying the highest quality medical products to its customers. BRM 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. 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 the most 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. Tools include but are not limited to Management and Feasibility Reviews, AS9102 First Articles, FMEA’s, Control Plans, IQ-OQ-PQ’s, Process/Product Validation and Lean/Six Sigma best practices.
Bally Ribbon Mills (BRM) designs, develops, and manufactures highly specialized engineered woven webbing, tapes, specialty fabrics, woven preforms, and two dimensional and three dimensional structural fabrics. With more than 95 years of textile manufacturing experience, BRM has earned a reputation for meeting new advanced design challenges. Working in aerospace, defense, medical, safety, automotive, commercial, and industrial applications, BRM offers ingenuity, technical know-how, extensive weaving capabilities, and rigorous quality assurance systems.
Posted February 21, 2019
Source: Bally Ribbon Mills (BRM)
