The certificate issued is for the following scope: The design and manufacture of cell locating devices for the pre-classification, display, storage and communication of cell images. The management of service activities relating to company products.
"Our quality system is a fundamental part of our business," said CEO Yvonne Mårtensson. "The certificate demonstrates that CellaVision is meeting the highest quality assurance standards for the manufacturing of in vitro medical devices, and will create new opportunities for CellaVision to export our products to a wider global market."
About ISO
ISO (International Organization for Standardization) is the world's largest developer of international standards. ISO standards specify the requirements for products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. For more information, please visit www.iso.org.
About CellaVision
CellaVision AB is an emerging high-tech company with a core competence in development of software for automatic image analysis of cells and cell changes and for applications in health and medical care. The company offers within sophisticated digital image analysis, artificial intelligence and automated microscopy. It develops and markets systems for automatic differentials of white blood cells and red morphology, and software for education and quality assurance of differentials.
The company headquarters are in Lund, Sweden. The company also has a U.S. subsidiary in Jupiter, Fl, USA. For more information about CellaVision, visit www.cellavision.com.
ISO (International Organization for Standardization) is the world's largest developer of international standards. ISO standards specify the requirements for products, services, processes, materials and systems, and for good conformity assessment, managerial and organizational practice. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. For more information, please visit www.iso.org.
About CellaVision
CellaVision AB is an emerging high-tech company with a core competence in development of software for automatic image analysis of cells and cell changes and for applications in health and medical care. The company offers within sophisticated digital image analysis, artificial intelligence and automated microscopy. It develops and markets systems for automatic differentials of white blood cells and red morphology, and software for education and quality assurance of differentials.
The company headquarters are in Lund, Sweden. The company also has a U.S. subsidiary in Jupiter, Fl, USA. For more information about CellaVision, visit www.cellavision.com.
For more information, please contact:
Yvonne Mårtensson, VD, CellaVision AB
Tel: +46 46 286 4400. E-mail: yvonne.martensson@cellavision.com
Hans-Inge Bengtsson, QA Manager, CellaVision AB
Tel: +46 46 286 4400. E-mail: hans-inge.bengtsson@cellavision.com
Yvonne Mårtensson, VD, CellaVision AB
Tel: +46 46 286 4400. E-mail: yvonne.martensson@cellavision.com
Hans-Inge Bengtsson, QA Manager, CellaVision AB
Tel: +46 46 286 4400. E-mail: hans-inge.bengtsson@cellavision.com