Biovica ISO 13485:2016 certificate renewal
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.
For more information
Anders Rylander, CEO Biovica
phone: +46 (0)18 444 48 35
email: anders.rylander@biovica.com
Biovica – Best Treatment from Day One.
Biovica develops and commercializes blood-based biomarker assays to evaluate efficacy of cancer treatments. Biovica’s assay DiviTum® measure cell proliferation by detecting a biomarker in the blood stream. The assay has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. The first application for DiviTum is monitoring of treatment for patients with metastatic breast cancer. Biovica's vision is that all cancer patients will get an optimal treatment from day one. Biovica collaborates with world-leading cancer institutes and pharmaceutical companies. DiviTum is CE-marked and registered with the Swedish Medicines Agency. Biovica's shares are traded on the Nasdaq First North Growth Market (BIOVIC B). FNCA Sweden AB is the company's Certified Adviser, info@fnca.se, +46 8 528 00 399. For more information please visit: www.biovica.com.
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