Voler Systems Continues Investments and Expands Services

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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SOURCE Voler

Theresa Shafer of Voler Systems, +1-408-252-9676