Swedish manufacturer Permobil has announced that its TiLite division has been awarded a quality management certification for its range of its made-to-measure wheelchairs.
The company has received the ISO 13485:2016 standard, which recognises an organisation’s ability to provide medical devices that “consistently meet customer expectations and regulatory requirements”.
Brad Wolfe, project leader at TiLite, said it took 18 months to secure the certification.
“Every department helped towards achieving this goal,” he added. “We have shown that we have robust systems in place for our ultra-lightweight and made-to-measure manual wheelchairs.
“This certification is further evidence of our unwavering commitment to quality,” adds Anna-Karin Wahlström, director of compliance EU-MDR. “We chose to pursue it because we hold ourselves to a higher standard. The TiLite unit joins ROHO in having achieved ISO certification.”
Set by the International Organisation for Standardisation (ISO), ISO standards are internationally recognised across 163 countries worldwide.
Chuck Witkowski, president of Permobil Americas, said: “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 news follows Permobil’s acquisition of Supportec, expanding its offering of seating and positioning solutions within Europe.