Built on Salesforce and Google Cloud

Post Market Surveillance Suite

Smarteeva believes strongly that Post Market Surveillance is one of the most underinvested areas of a Medical Device Company and it has the opportunity and the potential to make a big difference in a company’s performance both from a customer satisfaction perspective but also from a product quality and regulatory compliance perspective. See our solutions

Complaints Mgmt

Smarteeva’s Intake and Complaint Solution provides the next generation of complaints management by fully integrating risk management and customer self service. Utilizing embedded Artificial Intelligence, the solution lets you collect all necessary and complete initial complaint data, followed by the ability to run automated risk assessments to help determine the level of risk associated with the complaint. Furthermore, leveraging machine learning capabilities, the solution guides the users through the right investigation and assessment path to ensure a complete feedback loop and compliance with regulatory authorities such as FDA, EU, PMDA, TGA etc.

Field Notice Mgmt

Field Notification Management simplifies the process of creating and sending Safety, Quality, Recall, Service and other Notices to the customers, affiliates and distributors. By utilizing smart cloud technology, Smarteeva is able to track complete lifecycle of the Notice generation through review and approvals and smart audit trail. It then links to the Install Base and generates the list of notice receivers who are automatically notified and asked to fill out a feedback form acknowledging the notice receipt and capturing any additional info.

Adverse Event Mgmt

Adverse Event tracking and reporting is a very important function for any life science company. Smarteeva simplifies this process by integrating it with Complaint Handling and ERP. Utilizing our smart business rule configuration Smarteeva is able to automatically fill out most information so that regulatory staff can spend their efforts in crafting the right message to the agencies rather than doing data entry. Using Smart Audit Trail and Meaningful Data Change, Smarteeva is able make changes easily visible so follow up/supplemental reports can be triggered.

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POST MARKET SURVEILLANCE

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SERVICES

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