TiLite awarded certification

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Wednesday, November 11, 2020

LEBANON, Tenn. – Permobil’s manual wheelchair unit, TiLite, has been awarded ISO 13485:2016 certification for product design, development, manufacturing and distribution of its medical device products. “Permobil has created high quality, user-focused medical devices for decades,” said Chuck Witkowski, president of Permobil Americas. “We are passionate about creating our products with the highest standards for safety, performance and reliability that not just meet, but exceed, our end users’ expectations. I want to thank our team for their hard work and commitment in receiving this important certification.” The certification is an internationally recognized standard for quality management systems. It demonstrates an organization’s ability to provide medical devices that consistently meet customer expectations and regulatory requirements. Permobil notes that the U.S. Food and Drug Administration announced last year that it intends to harmonize and modernize their Quality Systems Regulation (QSR) for medical devices by transitioning to ISO 13485:2016 for its audit inspections.