Expanding on ISO 9001, this standard contains specific requirements for parts traceability and risk management activities throughout the design and development stages. It also requires process and software validations at defined intervals. Presented by independent risk management and quality compliance firm, DNV GL, ISO 13485 compliance is an important part of Portescap’s quality management system and demonstrates its consistency in design, development, production, storage and distribution.
As a result of ISO 13485 compliance, OEMs can be certain that products manufactured at Portescap’s 72,000-square-foot facility in Mumbai, India meet the highest standards for quality and consistency. The plant currently includes over 1,100 staff and is outfitted with machining, winding and injection molding equipment, as well as an electrostatic discharge (ESD) safe assembly facility.
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