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Sterling Receives ISO 13485 Certification For Medical Devices

Author: Dan Sterling | Date: February 10, 2009

SterlingTech Software, a leader in custom software solutions for the medical device industry, announced today that it has received ISO 13485 Certification.

ISO 13485 is an internationally recognized quality standard for the design, development, production, and sale of medical devices. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The certification process was expedited via a technology grant SterlingTech received last year from the State of New Jersey.

Whether a start-up or a seasoned developer, SterlingTech’s clients can be assured that all of the company’s development and testing processes, its equipment and its calibration are consistent with the rigorous standards set forth by the ISO.

ISO certification positively affects SterlingTech’s processes in numerous areas:

  • Software and Hardware
  • Development and Testing
  • Shipping and receiving
  • Contracts
  • Management
  • Supervision
  • Training
  • Documentation Control

SterlingTech uses an independent auditor who audits directly to the standard. Therefore, due diligence is automatically performed at every phase of the process. Start-ups can rely on SterlingTech’s certification while they are in the process of achieving their own.

“Even before receiving certification, our company always adhered to the guidelines for medical device development set forth by the International Standards Organization,” said Dan Sterling, SterlingTech’s President. “This certification is simply the next step in our growth as a company. In addition to validating our quality system and practices, it will allow our customers to streamline their auditing processes when selecting a medical device development partner.”

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