Sienna Receives ISO13485 Certification


Sienna have received formal certification that their Quality Management System complies with the requirements of ISO13485.

ISO 13485 is the best internationally-accepted model a medical device organization can implement to help demonstrate compliance to laws and regulations of the medical device industry. ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives. Increasingly, ISO 13485 is being required, or is at least beneficial, in supporting regulations around the world.

Sienna's Chief Operating Officer, Matthew Hoskin said "ISO 13485 certification is recognised as a harmonised standard by the European Commission. It allows Sienna to register their telomerase detection product as a CE marked, In Vitro Diagnostic (IVD) for human clinical use. Achieving certification takes a substantial investment in time and resources, but the return is significant because it creates a foundation on which to base IVD product registration in all our target markets around the world."

ISO13485 certification is an important step on Sienna's journey to launch the first ever in-vitro diagnostic test for telomerase as an adjunct to urine cytology, the most common non-invasive test for bladder cancer.


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