Crospon receives ISO 13485:2003 certification

[August 18th, 2008]
Crospon, the Galway based medical device developer today announced that it has received ISO 13485:2003 certification for its quality management system from the National Standards Authority of Ireland (NSAI).

ISO 13485:2003 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

Commenting, John O’Dea, CEO, Crospon said, “This certification represents an important step toward the company obtaining European regulatory approval for its EndoFLIP^® system” commented John O’Dea, CEO. “We expect to apply for formal European regulatory approval in the fourth quarter” he added.