Another SPV of Scope Fluidics with positive recommendation regarding ISO 13485:2016 compliance certification


grafikaBacteromic – a member of the Scope Fluidics S.A. Capital Group – has successfully passed the ISO certification audit in accordance with 13485:2016, meeting the requirements set out in the standard. The completion of the audit marks the achievement of an important milestone for the registration and certification of the BacterOMIC system. In addition, completion of the ISO audit confirms that the BacterOMIC system is designed and manufactured in accordance with the requirements of European regulations.

The audit was conducted by the Polish Centre for Testing and Certification (PCBC). The lead auditor informed Bacteromic about Centre’s positive recommendation regarding the certification of the quality management system with ISO 13485:2016 in the scope of: design, production and distribution of in vitro diagnostic (IVD) systems used for quantitative determination of drug susceptibility of microorganisms in tested specimens.

– The successful implementation of the quality management system in the design and production of the BacterOMIC system is a result of incredible commitment of all team members. The implementation is also of operational importance to us, as in fact it allows us to better control the quality of design and manufacture of the system’s components – this is of utmost importance when preparing the system for its market launch – explains Dr Seweryn Bajer-Borstyn, BacterOMIC product manager.

At the beginning of April, the Company announced that it commenced a validation testing program of the BacterOMIC system in an external laboratory. Validation in an external laboratory, using clinical samples, is an assessment of the effectiveness of the BacterOMIC system as part of pre-registration tests. The tests will take place at three sites, of which at least two will be external laboratories. The Company expects to complete pre-registration testing of the BacterOMIC system in Q2 or Q3 2021.

The BacterOMIC project is intended to respond to the growing phenomenon of antibiotic resistance. The system is expected to make patient treatment faster and more effective by pinpointing the best targeted therapies for a given patient. BacterOMIC will offer a uniquely broad range of antibiotics tested quantitatively in each individual test and a wide range of antibiotic concentrations. As part of the development work, it is also planned to develop a test panel to enable the testing of combinations of antibiotics in the cases of the most difficult infections, where antibiotics administered alone are not effective.