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Latest From Siemens AG
Two Edwards quality experts explain to Medtech Insight how the firm is benefiting by using a new CAPA framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA.
Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.
German reimbursement of COVID-19 confirmatory tests has been reduced by one third, a decision that has frustrated both the testing labs and the diagnostics manufacturers who jointly provided the basis of the system that kept the coronavirus to within manageable proportions nationally.
Test kit and lab firms spent tens of thousands of dollars in the first quarter of 2020 lobbying legislators to win provisions in coronavirus protection laws to ensure COVID-19 diagnostics would be a top US legislative priority.
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