Due to restrictions related to the COVID-19 pandemic, audits were performed online under difficult conditions via the Microsoft Teams application.
"LINET has been building and improving a world-class quality and environmental management system for a long time. The defended certificates according to the international standards ISO 13485: 2016, ISO 9001: 2015, MDSAP and ISO 14001: 2015 are the proof", said Jan Štěrba, Head of Regulatory Affairs and Certifications.
LINET has held the MDSAP certification (Medical Device Single Audit Program) since 2018 as one of the first companies in the world. In the MDSAP program the compliance of the quality management system, including the specific requirements of the USA, Canada, Australia, Brazil and Japan, is regularly checked through audits.
The defended certificates are one of the key inputs in the process of launching products on various markets and in tenders. They confirm that we can continuously provide safe and functional products and that our system complies with international industry standards.