Permobil‘s manual wheelchair unit, TiLite, has been awarded ISO 13485:2016 certification for the product design, development, manufacturing, and distribution of its medical device products, the company announces in a media release.
“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.”
— Chuck Witkowski, president of Permobil Americas
“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 ultra-lightweight and made-to-measure manual wheelchairs.”
— Brad Wolfe, project leader at TiLite
“This certification is further evidence of our unwavering commitment to quality. We chose to pursue it because we hold ourselves to a higher standard. The TiLite unit joins ROHO in having achieved ISO certification.”
— Anna-Karin Wahlström, director of compliance EU-MDR