Smarteeva develops complaint management software that automates post-market surveillance for medical device companies, utilizing AI-driven risk assessments and automated reporting to enhance efficiency. By streamlining the tracking of complaints and adverse events, Smarteeva enables clients to maintain regulatory compliance while reducing reporting time by 40%.
Funding
$500K raised to dateRaised to date based on public sources. This may differ from the amount the company actually raised and is based only on what is publicly available on the internet.
Founders
Product
Problem
Medical device companies face increasing regulatory scrutiny and complexity in post-market surveillance, making it challenging to efficiently track complaints, adverse events, and recalls. Traditional, manual processes are often time-consuming, error-prone, and hinder timely reporting to regulatory agencies. This can lead to compliance issues, increased costs, and potential risks to patient safety.
Solution
Smarteeva offers a complaint management software solution that automates post-market surveillance for medical device companies, streamlining the tracking of complaints and adverse events. The platform leverages AI-driven risk assessments and automated reporting to enhance efficiency and ensure regulatory compliance. By integrating risk management, customer self-service, and partner self-service, Smarteeva provides a comprehensive system for managing the entire post-market surveillance process, from initial complaint data collection to automated report generation. The system is built on the Salesforce Platform and AWS, offering security, reliability, and functionality.
Target Audience
The primary target audience includes medical device companies that need to streamline their post-market surveillance processes, maintain regulatory compliance, and improve patient safety.
Features
- AI-driven complaint management with automated decision trees
- Automated report generator for MDRs, MIRs, CVRs, and PSURs
- Recall Management System for creating and sending quality, safety, recall, and service notices
- MDREngine aggregates medical device regulatory data about adverse events, recalls, warning letters, and clinical studies
- Real-time validation checks and smart audit trails
- Integration with customer and partner self-service portals
- Integration with Business Intelligence tools
- Data warehousing capabilities
- Secure platform built on Salesforce and AWS with granular access rights