Uppsala, Sweden, October 25, 2019. Biovica, active in cancer diagnostics, announced today that the company has renewed their ISO 13485:2016 certificate for three years following an extensive renewal audit with the company’s accreditation body. The certificate covers the development, manufacturing and sale of DiviTum®.
“The renewal of the certificate is important for Biovica as it proves that our quality management system fulfills the global quality requirements. The quality management system is a pre-requisite for market approval in both US and Europe and hence a must in order for Biovica to fulfill the vision of contributing to best treatment for cancer patients.”, says Anders Rylander, CEO at Biovica.
Biovica has been ISO:13485 certified since 2010. ISO 13485 is an international standard that defines the requirements of the Quality Management System (QMS) for manufacturers of medical device. The certificate has been renewed through a comprehensive renewal audit by Biovica's accreditation company. The certificate covers the development, manufacturing and sale of DiviTum.