TiLite, Permobil’s manual wheelchair division, has won ISO certification.
In a news announcement, Permobil said the ISO 13485:2016 certification is for “product design, development, manufacturing, and distribution.”
The TiLite division, based in Pasco, Wash., designs and manufactures made-to-measure ultralightweight manual wheelchairs.
Chuck Witkowski, President of Permobil Americas, said in the announcement, “Permobil has created high-quality, user-focused medical devices for decades. 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.”
Brad Wolfe, the TiLite project leader, said of the certification, “We started the process 18 months ago, and every department helped towards achieving this goal. We have shown that we have robust systems in place for our ultralightweight and made-to-measure manual wheelchairs.”
Permobil described the ISO 13485:2016 standard as “an internationally recognized standard for quality management systems, and certification demonstrates an organization’s ability to provide medical devices that consistently meet customer expectations and regulatory requirements. The U.S. Food and Drug Administration (FDA) 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.”
TiLite’s lineup comprises rigid and folding ultralightweight wheelchairs using titanium and aluminum frames for pediatric and adult consumers.
