High Quality Standards

8/2020

High Quality Standards in Laboratory and Medical Devices

Since the beginning, ProGnosis Biotech has established an advanced quality system that ensures the provision of high-quality products and services. Following the Total Quality Management approach (TQM), our priority is the continuous improvement of quality and performance in all the organizational functions, departments, and processes of the company.

ProGnosis Biotech is certified with the ISO 9001:2015, for the development, manufacturing & marketing of diagnostic and laboratory products. Our company has been also certified with the ISO 13485:2016, as recently entered the market of clinical diagnostics by launching test kits detecting the presence of COVID-19. The specific certificate confirms that ProGnosis Biotech is qualified to produce and distribute In Vitro Diagnostics Medical Devices (IVD’s), conforming also with the essential requirements listed in Annex I of the European in vitro Medical Device Directive 98/79/EC (IVD).

At ProGnosis Biotech we aim to become a leading player in the food diagnostics and to establish a significant presence in the clinical diagnostics industry by promoting consumers’ wellbeing based on high-quality standards.