Avicena is delighted to announce that the company has received its official ISO 13485 certificate.
This important accreditation covers both our cutting-edge Sentinel instrument and chemistry manufacturing facilities in West Perth and Bentley, Western Australia.
ISO 13485 certification is an internationally recognised standard that demonstrates our commitment to the highest level of safety and quality management as a medical device manufacturer and is required by various national regulators.
Our independent auditor (an international notified body) described Avicena’s undertaking to achieve ISO certification for two manufacturing facilities as a “behemoth effort in a very short time.”
We thank our exceptional engineering, chemistry, procurement, and manufacturing teams for their wholehearted efforts in achieving this critical milestone. Only a handful of MedTech companies in Western Australia hold this certification.
The significance of the accreditation should not be understated, as it facilitates the achievement of regulatory authorisations of the Sentinel in Europe, the U.K. and various other countries.
The certification is also a prerequisite to selling our biosecurity system to defence and government-related buyers in these markets.