| Certifications |
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ISO 13485:2003 Certification
ISO 13485:2003 is 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. |
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HL7: The worldwide leader in interoperability standards
Health Level Seven International (HL7) is an ANSI-accredited standards developing organization (SDO) and is the global authority on standards for interoperability of health information technology. With members in more than 55 countries, HL7 is involved in worldwide efforts to improve healthcare through information technology, and it is a founding member of the Joint Initiative Council, an international council on global health informatics standardization that is committed to developing a single standard for a single purpose. HL7 also as an agreement with the International Organization of Standardization (ISO) in which HL7 submits its ANSI-approved standards or draft standards for trial use (DSTUs) directly to ISO to approval.
Core Sound Imaging is a member of HL7. They are committed to following HL7 standards and following all regulations that affect their clients. |
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Mirth Certified
Mirth is an open source solution for healthcare interoperability that has been providing HL7 message integration for 17 years. Mirth Connect and the Mirth appliance have interfaced with virtually every EMR on the market. Mirth Certification is provided through passage of a comprehensive training and exam process. |
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ASQ Membership
ASQ advances learning, promotes quality improvement, and unites quality professionals and organizations worldwide. They provide networking, access to information, solutions, and professional development resources.
Core Sound Imaging and its employees are also members of many organizations in order to stay current with industry trends legislation, and other issues that allow them to continually enrich their product offering and deliver products that best serve their clients. |
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