Quality Management System

PentaBase is manufacturing and marketing oligonucleotides and in vitro diagnostic products based on standard and own proprietary chemistries, for researchers, IVD companies and healthcare customers worldwide. As part of our continuing efforts to provide high quality products and services to our customers, PentaBase has developed and implemented a quality management system that meets the requirements of both ISO 9001:2015 and ISO 13485:2016 quality standards. While ISO 9001:2015 is focused on continuous improvement of processes to meet the needs of customers and other stakeholders, ISO 13485:2016 is specifically focsused on the requirements for a comprehensive quality management system for the design and manufacture of medical devices.