Portescap Brushless DC Motors Achieve ISO 13485 Certification for Respirators
February 04, 2021
Portescap, a global manufacturer of miniature and specialty motors, announced that its slotless brushless DC motors for respirators have received ISO 13485:2016 certification.
Per the company, this compliance ensures that medical device original equipment manufacturer's (OEM) motion control systems are manufactured to a high quality standard.
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 aware that products manufactured at Portescap’s 72,000-square-foot facility in Mumbai, India meet high 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.
For more information visit: www.portescap.com