SUNNYVALE, Calif., April 7 /PRNewswire/ -- Voler Systems (http://www.volersystems.com) 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 its 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 ISO 13485 and QSR compliant system gives them and their customers."
About Voler Systems
Voler Systems (http://www.volersystems.com) is a full-service consulting firm that helps emerging and established firms commercialize novel and innovative medical devices. Clients have turned to us for strategic consulting and tactical solutions to understand and overcome regulatory, compliance, and clinical trial challenges at all stages of the medical product lifecycle. Voler has assembled a team of engineers skilled in multiple disciplines and dedicated to designing and developing medical devices. We have the experience to guide you through product development and product launch, and to help you ensure compliance. The medical backgrounds of Voler engineers include prototypes, device design and test equipment for critical applications such as class 3 medical devices.
Media Contact: Theresa Shafer Voler Systems 408-252-9676 http://www.volersystems.com
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