InLimbus NewsbyBen Liesfeld“The varvis® Software: The first genomics end-to-end software certified as IVDR Class C device”Genetic diagnostic laboratories now have access to the first complete genomics software solution which is certified as a Class C device…May 31
InLimbus NewsbyBen LiesfeldQ&A: The role of the IVDR conformity assessment in genetic diagnosticsNow that the regulation on in-vitro diagnostic devices (IVDR) explicitly regulates in-house devices, or laboratory-developed tests (LDTs)…May 31
InI3CGLOBAL BlogsbySEO AgencyEU IVDR Regulation with i3c GlobalThe in vitro diagnostic medical device landscape underwent a significant shift with the implementation of the European Union (EU) In Vitro…Mar 29Mar 29
InLimbus NewsbyBen LiesfeldThe IVDR affects how genetic testing laboratories can operate all over EuropeThe previous directive on in-vitro diagnostic medical devices (IVDD) did generally not apply to devices that were manufactured and used…Jan 7, 2020Jan 7, 2020
InI3CGLOBAL BlogsbySEO AgencyThe Role of I3CGLOBAL IVDR Technical Documentation Consultants in the Medical Device IndustryAs the medical device industry undergoes transformative changes, the implementation of robust technical documentation has become…Dec 6, 2023Dec 6, 2023
InLimbus NewsbyBen Liesfeld“The varvis® Software: The first genomics end-to-end software certified as IVDR Class C device”Genetic diagnostic laboratories now have access to the first complete genomics software solution which is certified as a Class C device…May 31
InLimbus NewsbyBen LiesfeldQ&A: The role of the IVDR conformity assessment in genetic diagnosticsNow that the regulation on in-vitro diagnostic devices (IVDR) explicitly regulates in-house devices, or laboratory-developed tests (LDTs)…May 31
InI3CGLOBAL BlogsbySEO AgencyEU IVDR Regulation with i3c GlobalThe in vitro diagnostic medical device landscape underwent a significant shift with the implementation of the European Union (EU) In Vitro…Mar 29
InLimbus NewsbyBen LiesfeldThe IVDR affects how genetic testing laboratories can operate all over EuropeThe previous directive on in-vitro diagnostic medical devices (IVDD) did generally not apply to devices that were manufactured and used…Jan 7, 2020
InI3CGLOBAL BlogsbySEO AgencyThe Role of I3CGLOBAL IVDR Technical Documentation Consultants in the Medical Device IndustryAs the medical device industry undergoes transformative changes, the implementation of robust technical documentation has become…Dec 6, 2023
InI3CGLOBAL BlogsbySEO AgencyThe Role of IVDR Consultants in the Medical Device IndustryIn the swiftly evolving landscape of the medical device industry, the implementation of regulatory standards is critical to ensure the…Dec 5, 2023
InLimbus NewsbyBen LiesfeldAn MDCG guideline for laboratory developed tests under IVDRThere have been a lot of discussions about what IVDR Art 5(5) means for genetic diagnostic labs. In January 2023, the Medical Device…Jan 25, 2023
InLimbus NewsbyBen LiesfeldLimbus achieves EN ISO 13485:2016 certificationLimbus’ quality management system has now been certified to be compliant with the medical device standard EN ISO 13485:2016. This paves…Jan 30, 20201
