31.07.2020

Scope Fluidics subsidiary obtains ISO 13485:2016 certification

Curiosity Diagnostics, owned by Scope Fluidics – a biotechnological company listed on NewConnect, owner of innovative medical diagnostics projects, following an audit conducted by an independent body, received a certificate which confirms compliance with the ISO 13485:2016 standard. Obtaining the certificate, which confirms the implementation of the quality management system in the company, is a huge step forward in the process of registering the diagnostic systems

– We are very pleased to announce that we have obtained a certificate which confirms the compliance of our quality system with the ISO 13485:2016 standard. The scope of the certificate covers all areas which are important from the point of view of a medical device manufacturer: research and development, production and sales. Obtaining the certificate crowns many years of work and great effort of the whole team. It is not only a reason for us to be proud, but also a commitment to continue development and maintain the highest quality. Certification is also a milestone that brings us closer to registering the PCR|ONE system and increases our competitiveness on the market – says Marcin Izydorzak, co-founder, key shareholder and Member of the Board of Scope Fluidics S.A.

The company passed the audit successfully and in June it completed the ISO 13485:2016 certification, dedicated to the Quality Management System for Medical Devices, and thus it proved compliance with international standards. The certificate covers the design, manufacture and distribution of systems and cartridges with in vitro molecular diagnostic reagents (IVD) used to diagnose and monitor the presence of pathogens in tested samples.

The audit was conducted by the Polish Centre for Testing and Certification. The key assumption of the certification is to guarantee safety and high quality of products, as well as to confirm compliance with legal requirements. Passing the ISO 13485 audit and obtaining certification proves that the PCR|ONE system is reaching commercial maturity. The company has thus completed one of the milestones for the registration and certification of the PCR|ONE system.