Successful ISO13485 Re-certification Audit for Sienna


Sienna has maintained an important cornerstone in its vision to become a hub for the development and commercialisation of IVD products. Last week the company successfully achieved re-certification to the ISO13485 International Standard for Medical Device Quality Management following a two-day audit by the British Standards Institute (BSi).

Sienna uses this Quality System to drive process improvement and consistency and ensure its products are supplied with the highest quality. Compliance to the standard is a requirement for the supply of IVD products in key markets.

Matthew Hoskin, Sienna’s CEO, said “We are very proud of this certification as it demonstrates the commitment of the Sienna team to providing quality products that meet customer expectations as well as international regulatory requirements. Achieving certified compliance to such a rigorous standard is a significant accomplishment for a company of our size, and this helps demonstrate our credibility and capability in the development of tests for the large global IVD market”.

ISO13485 certification is an important pillar in Sienna’s CE Marking compliance for the European market, and TGA regulatory compliance for the Australian market. Along with ISO13485, Sienna’s quality system is also aligned with the FDA regulatory requirements.


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