SkylineDx achieves new milestone with ISO 13485:2016 certification
ROTTERDAM (the Netherlands) and SAN DIEGO (US), February 18, 2021: today, SkylineDx announced that it received the esteemed ISO 13485:2016 Quality Management System certificate from notified body BSI Netherlands, after their successful audit in November 2020. This internationally recognized standard of excellence is a stringent guideline for medical device manufacturers to address the regulations, responsibilities and demonstrate the commitment to the safety and quality of the developed medical devices. To achieve this certification, SkylineDx had to demonstrate consistent design, development and servicing of their molecular tests, that they are safe and effective for their intended purpose.
“Medical device manufacturing is one of the most regulated sectors in which significant requirements must be met”, comments Dharminder Chahal, CEO SkylineDx. “This external confirmation is an important milestone for SkylineDx as it validates the compliance to stringent laws and regulations. It reflects our risk-based decision-making throughout the company to keep focused on developing safe and high-quality products for patients”.
SkylineDx is a biotechnology company, focused on research & development of molecular diagnostics in oncology and inflammatory diseases. The company is headquartered in Rotterdam (the Netherlands) and complemented with a field medical and scientific affairs team in the US and a CAP/CLIA certified laboratory in San Diego (California). SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predict a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. To learn more, please visit www.skylinedx.com.
Link to ISO 13485:2016 Certificate on website SkylineDx (click here)