During a recent webcast with RAPS, Sue Spencer, Lorry Weaver & Christie Hughes discussed the challenges & experiences of the past year with the current pandemic and how in the diagnostic world, manufacturers have had to develop new devices at breakneck speed and get them to market to help battle a public health pandemic. As our knowledge of COVID-19 matures and as we understand more about how tests can help at difference points in the care pathway, manufacturers are now looking to repurpose emergency use applications into global registrations.
Although COVID-19 has put the design and development process into a pressure cooker, it is still necessary to have a well thought-out plan for moving your IVD along a development pathway to succeed for emergency use applications as well as for traditional global submissions. Whether you are developing SARS-CoV-2 assays or are just interested how to efficiently build your global submissions, this presentation aimed to share some of those best practices using SARS-CoV-2 as a case study.
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