Voler Systems has launched a “Quality System for Medical Device Innovation Program” which provides full-service consulting from concept and design to production of devices for human use. The current economic conditions are not deterring Voler from investing in key programs that are critical to meeting our customers’ needs and reducing time-to-market for new medical devices. During the economic recovery to come, Voler will be one of the strong companies, and Voler continues to selectively invest to be able to provide more and better services. This initiative will foster faster innovation, design, and time-to-market while complying with strict FDA regulations.
“We are extending our design practice to include the production of prototype devices for human use in addition to our Design Control system for designing medical devices. Some existing customers are interested in this new capability and are eager to have us develop the complete product under our Design Control and have us make prototype quantities for human use,” stated Walt Maclay, president of Voler Systems.” We have an outstanding team of people and are investing in them to enhance our product development and rapid approval of safe, effective, and innovative medical devices,” he vowed.
The ISO 13485 standard details the requirements for a comprehensive quality system for the design and manufacture of medical devices including inspection and traceability for implantable devices. Compliance with ISO 13485 requires advanced knowledge, quality, and a documented design control process. Voler has implemented such a quality management system.
Gregory Meyer, of the American Society for Quality Biomedical Division commented, “By implementing a quality system that focuses on design Voler has taken all the right steps to bring innovative devices smoothly into full scale regulated commercial manufacturing. That’s the advantage an ISO13485 and QSR compliant system gives them and their customers.”