SterlingTech Software, a leader in custom software solutions for the medical device industry, announced today that it has received a grant from the State of New Jersey to pursue ISO 9001 certification. The company also announced that John Campbell, Director of Quality Assurance, has moved to SterlingTech's corporate headquarters and technology center in Rochelle Park, New Jersey to oversee the certification process.
As part of the validation process, SterlingTech will also be applying for ISO 13485 certification, a medical device-specific subset of ISO 9001.
"The most vital aspect of any medical device development company is its quality system," Mr. Campbell said. "ISO certification represents the next logical step in SterlingTech's growth. It provides another level of assurance to new and existing clients that the work we do adheres to the stringent guidelines set forth by the International Standards Organization."
Mr. Campbell brings more than 30 years of experience to the certification process. Before joining SterlingTech, he most recently served as Director of Engineering for Sulzer Intermedics. Prior to that, he was Manager of Quality Assurance for Texas Instruments.
"In addition to validating SterlingTech's quality system and practices across the board, ISO certification will allow our customers to streamline their auditing processes when selecting a medical device development partner," added Dan Sterling, SterlingTech's President. "And I'm thrilled that a man with John Campbell's medical device expertise and experience will be overseeing this important project."
About SterlingTech Software
Founded in 1998, SterlingTech Software provides full life cycle software development, testing and validation services exclusively for the medical device industry. SterlingTech is a leading provider of innovative software solutions for both therapeutic and diagnostic devices in the cardiovascular, neurological, orthopedic, imaging and glucose monitoring markets. SterlingTech's work has resulted in successful FDA 510(k), PMA and CE submissions for numerous medical device projects. STS offers a free consultation that includes a detailed software analysis and project plan for any medical device. General inquiries: Phone: 201.227.7569 ext. 201; email: info@sterlingtechsoftware.com
www.sterlingtechsoftware.com