However, the company said it will delay a submission for its next-generation Zio cardiac monitoring system until remediation ...

the need for complex data management systems, and the ongoing evolution of regulatory landscapes. Integrating novel ...

The U.S. Food and Drug Administration ... procedures applicable to the quality control unit. The FDA also cited inadequate control over computers and other IT systems, as well as poor ...

ticagrelor – a major unmet medical need in heart attack patients requiring surgery Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system ...

Successful MDSAP certification confirms compliance with Health Canada and U.S. FDA quality management system requirements, replacing FDA audit and inspection if required Health Canada and U.S. FDA ...