Our client is a mid-sized manufacturer of Device Products, headquartered in the US and specializing in blood products. They needed to implement a Safety Database that would support global regulatory requirements, including eMDR and MIR, associated with the safety of global medical device products. Our client has experienced some challenges around the classification of their products, with some markets considering them devices, while others drugs. In addition, they had a requirement for a feature to support the processing of Technical Product Complaints. The solution needed to provide integration with their Clinical Data Management system to include adverse events reporting during clinical trials.
Read our latest case study and learn how we successfully implemented Oracle Argus to support Adverse Events and Technical Product Complaints to meet regulatory requirements.
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