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SUNNYVALE, Calif., Nov. 13 /PRNewswire/ -- Voler (http://www.volersystems.com) announced today that it is expanding current medical device design capabilities beyond prototypes and custom test systems to include the design of production medical devices for human use. "Voler continues to invest in upgrades to our medical device design capabilities and to add to our multidisciplinary team," stated Walt Maclay, president of Voler. "In the face of increasing customer demand we sought independent verification and instruction by a Fellow of the American Society for Quality (ASQ), a leader in quality initiatives and quality-assurance methodologies, to ensure compliance with government Medical Device Design Control regulations."
"These certifications are granted to individuals who have demonstrated a clear understanding of the Medical Device Design Control Process, and possess a clearly written and compliant set of procedures for federal medical device product design quality and regulatory compliance from product concept to transfer to production. The overall results from the training indicate that Voler's process is a very comprehensive solution for the medical device industry. Certification is recognition of attaining advanced knowledge, quality and skills in the product medical device design control process," stated Barry Craner, CQA-Biomedical Auditor and ASQ Fellow.
"We've designed devices for animal trials and proof of concept
evaluation. With this certification we are extending our design practice to
include the design of production devices for human use. Some existing
customers are interested in this new capability as well as some new
prospects that are eager to have us develop the complete product under our
Design Control, so they can transfer it directly into production," said
Walt Maclay, president of Voler. "Our company has been at the forefront of
design of high quality, yet cost-effec
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