We are proud to announce that our manufacturing facility in Eysins, Switzerland has been granted ISO 13485:2016 and Medical Device Single Audit Program (MDSAP) certifications for the design, development, production, and distribution of in-vitro diagnostic test kits and reagents for the automated testing of autoimmune diseases and allergies.
The ISO 13485:2016 is an international standard for Quality Management Systems that demonstrates manufacturers’ ability to meet the IVDR quality requirements. The MDSAP certification streamlines the regulatory audit process for medical device manufacturers. MDSAP reports are accepted by the Food and Drug Administration (FDA).
“Receiving the ISO 13485:2016 and MDSAP certifications for our autoimmune disease and allergy testing activities at our Swiss manufacturing site is a significant milestone for our company. It underscores our commitment to delivering high-quality in vitro diagnostic solutions to our customers in Europe and North America,” said Michael Campbell, Chief Regulatory Affairs and Quality Officer.
Please visit the TUV website for details and certificates’ validity: ISO 13485:2016 and MDSAP certificate.
To learn more, please visit the Alba and MosaiQ® solution sections of our website.
