Genomtec SA has been certified in accordance to ISO 13485 standard for its quality management system compliance via audits carried out by TÜV Rheinland – a prestigious, independent Certification Body. The certificate was awarded for the design and development of IVD devices for the detection of pre-determined pathogens and confirms Company’s top commitment towards quality development of medical devices. Obtained certification is necessary for the purpose of Genomtec ID mobile genetic diagnostic platform registration that is planned for mid-2022.
In August 2020, a second certification audit took place at the Company by the TÜV Rheinland Certification Body and since then the Company has been waiting for its to be issued. The granted certificate expirers on November 2023.
The ISO 13485 standard is an effective tool informing of the comprehensive Quality Management System use in the area of medical devices. The adoption of ISO 13485 standard provides Genomtec with a practical work-frame being implemented in accordance to the Medical Device Directives and other regulations and obligations. It also confirms Company’s commitment towards the safety and quality of manufactured medical devices. Moreover, it increases the market opportunity of the Company’s flagship project, i.e. Genomtec ID, simultaneously being a crucial element of its industrialization the process.
– The ISO 13485 certificate is yet another very important step towards commercialization of Genomtec ID. We have confirmed that our quality management system is compliant with the highest global standards. Conformance to the standard gives us a competitive product advantage and will certainly facilitate access to the foreign markets. Our future customers received confirmation that the Genomtec ID mobile genetic diagnostic platform will be made with an adequate diligence and that the product it is completely safe to use. The entire team has worked extremly hard to achieve this top level of quality. We want to continue our development, raising the standards-bar high – said Miron Tokarski, Co-founder and President of Genomtec.
The certificate was awarded by TÜV Rheinland – a market-leading Certification Body in the field of design and development standards compliance in Europe. The company is part of the TÜV Rheinland Group, a leading international conglomerate providing services to the industry worldwide. ISO 13485 is a standalone Quality Management System standard for medical devices and IVD products derived from the family of internationally recognized and accepted ISO 9000 quality management standards. It is much more detailed and requires a carefully documented Quality Management System operations in place.
ISO 13485 standard was written to support medical device manufacturers in developing and sustaining quality management systems that provide their processes’ effectiveness. This standard ensures the consistent design, development, manufacturing, installation, and delivery of medical devices that are safe for their intended use.
