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News

Cardiocom achieves ISO 13485:2003 medical device certification

Cardiocom : 06 November, 2007  (New Product)
Cardiocom Multi-Disease Management has achieved ISO 13485:2003 medical device certification from BSI Management Systems.
Cardiocom, a leader in developing and manufacturing home telemonitoring equipment and chronic disease management software, launched its products in Europe earlier this year and plans to provide telemonitoring systems in Canada in 2008.

ISO 13485:2003 is an internationally recognised Medical Device Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO). To be certified to the standard, companies must implement a Medical Device QMS ensuring steps to identify, manage and minimise the risks involved with the design and manufacture of medical devices. Certification to ISO 13485:2003 reinforces to customers, through an independent third-party, that Cardiocom operates their Medical Device QMS in accordance with their standard.

Certification under the ISO standard was granted to Cardiocom in recognition of their superior compliance with requirements for implementation of comprehensive quality management systems.

The systems include the operational procedures used in the design and manufacture of Cardiocom’s home telemonitoring products. Cardiocom’s investment in training and continuous quality control, enable the company to provide the highest quality remote home monitoring solutions for patients with chronic disease.

'Our success in achieving ISO 13485:2003 certification is due to the outstanding dedication and teamwork of our employees who embrace our quality processes' said Daniel L Cosentino, president. ' Our goal is to continue to provide our customers with the highest quality products and services expected of a major designer and manufacturer of telemonitoring devices.'

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