Genomtec S.A.

Regulatory Filings • Aug 6, 2021

TÜV Rheinland has issued ISO 13485 certificateManagementBoard of Genomtec S.A. ("the Issuer") hereby announces that as of today,i.e. on 6th Aug 2021, has been awarded by TÜV Rheinland the standard ISO13485 certificate.TÜV Rheinland is a leading certification bodyin the European certification and research services segment. The companyis part of the TÜV Rheinland Group, an international blue-chipconglomerate providing services to the industry worldwide.Thecertificate was issued for the design and development of the in-vitrodiagnostic systems.The Company underwent the secondcertification audit by TÜV Rheinland certification body in August 2020and since then the Company has been waiting for the above certificate tobe issued. The certificate is valid until November 2023.Obtainingthe certificate that confirms Company's conformance to and properimplementation of a quality management system is an important steptowards registration of the Genomtec ID diagnostic platform. The ISO13485 standard is an efficient solution to meet the comprehensiverequirements of the Quality Management System. The adoption of the ISO13485 standard provides the Issuer practical means of implementation ofthe directives on medical devices, regulations and obligations, and alsoensures its commitment to the safety and quality of manufactured medicaldevices. Having certification increases overall performance, managesrisks, and increases market opportunities.Obtained certificationconfirms commercial maturation of the Company's flagship solution and isan important element in the industrialization stage. Therefore, in theopinion of the Management Board, this information meets the criteria ofconfidential information within the meaning of Art. 7 sec. 1 MAR.