04/24/2009
Chicago, IL – Radius Product Development is proud to announce two important milestones for its Chicago office: the recertification to ISO 9000:2008 for consumer product development and the registration to ISO 13485 for the design of medical devices.
Since its inception, Radius has prided itself on the relationship it builds with its diverse clientele: one of trust and assurance. The company, as a whole, has always strived to enhance customer satisfaction, while continually improving its performance. With ongoing ISO registration, Radius can safely assure customers that it will fulfill their quality and regulatory requirements, adding even more value to its client services.
During the two-day audit on March 31 and April 1, various team members were interviewed and reviewed to ensure that each individual is focused on the ongoing commitment to, and use of, the Radius Quality Management System. Team members were able to thoughtfully answer questions and demonstrate compliance regarding the development process, including the design history files that result of this process, guide the DNV auditor through a maze of ever-changing client requirements, and weave the tapestry that is the proposal development process.
“We chose DNV as our registrar because their reputation is one of rigor, impartiality, discipline, trust, and expertise. This reputation closely mirrors ours and we believed that ours would not be a sandbox registration, but would instead have deep and profound meaning to our staff, to our clients, and ultimately, to the end users of the products and devices we are entrusted to design”, said Joe Tokich, Director of Product Development in the Chicago office.
“The auditor was highly complimentary of the continual improvements and of the evolution of the QMS,” he continued. “Now, more than ever, there’s an obvious momentum moving our system forward. We’ve demonstrated the very essence of why we are a medical device design firm: skill, willingness, desire, knowledge, and passion.”