Core Sound Imaging, Inc. announced today that the company has achieved ISO 13485:2003 Certification, an internationally recognized quality standard that ensures medical device manufacturers have comprehensive management systems place that will safely design, develop, manufacture, and distribute medical devices.

ISO 13485 certifies the following:

  • An organization consistently demonstrates the ability to provide medical devices and related services that meet both customer expectations and regulatory requirements
  • The work environment contains controls that will ensure product safety
  • Risk management activities are implemented during product development
  • Specific requirements are set for the verification of corrective and preventive actions

Mark Smith, President of Core Sound Imaging, reports:

Core Sound Imaging undertook this rigorous certification process as part of our commitment to Quality Management and assurance that all Core Sound Imaging medical devices meet international standards and regulatory requirements.  The ISO 13485 certification is another milestone for Core Sound Imaging and is a testament to our continued growth and position as a leader in web-based diagnostic imaging and workflow solutions.

 

 

Certificate Organization: NSAI

Registration Number: MD19.4618

Registration Date: February 22, 2011

Expiry Date: February 201, 2014

NSAI, the National Standards Authority of Ireland is a leading Notified Body for medical device certification services.