We are now ISO 13485 certified.

We are proud to announce that we are now certified with ISO 13485, within the scope “Design and Development and Service Provision of In Vitro Diagnostic Medical device software”.

The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

We have developed and implemented our quality management system in order to make sure that we have indicated all possible risks towards patient and users safety, plus also taken the necessary measurements to avoid them. Our decision to work towards the ISO 13485:2016 accreditation demonstrates our commitment to providing high-quality and consistent products and services to our clients, while taking this route we also prepare ourselves for the 2017/746 IVDR.

To become ISO 13485:2016 compliant, we worked intensively for 4,5 months with Star, our strategic partner in meeting regulatory requirements, to finalise and fully document our Quality Management System, according to international standards. Following Stage 1 internal audit, we underwent a screening process and review by Lloyd’s Register, our external auditor, to determine any gaps. Finally, all management system documentation passed both the initial and main audit assessment without any non-conformities.

Following this great milestone, we are now legally entitled to commercially launch version 1.0.0 of our Phivea®Platform, the novel screening tool for the detection of Klinefelter syndrome, in the beginning of 2022.