Simplify, Streamline & Secure your Post-Market Surveillance Duties

Our cutting-edge solutions use AI to optimize Post-Market Surveillance, driving improvements in quality, compliance, and customer experience.

Work with Us

    30% MDRs sent to FDA goes through Smarteeva

    60% of Complaints are fully automated with Smarteeva

    Companies that trust Smarteeva

    Top pioneers in launching self-monitoring blood glucose meters.
    Premier Manufacturer in Continuous Glucose Monitoring Solutions
    Recognized as a leading global provider of medical imaging devices. 
    Top trailblazers of minimally invasive ultrasonic technologies for active healing
    A leading producer of cardiovascular devices with an extensive portfolio.
    A leading supplier of urodynamic testing products for urinary incontinence.
    Global innovator in insulin delivery and diabetes management technology

    Smarteeva’s suite of solutions is crafted to meet the specific needs of your medical device company. Here’s a glimpse of what we provide:

    Complaints Management

    Benefit from automated solutions for complaints handling and adverse event reporting.

    Product Registration

    Smarteeva’s automated solution streamlines the end-to-end product registration process while providing comprehensive management of product portfolios with worldwide visibility.

    Regulatory Reporting

    Use advanced analytics to generate PSURs and other regulatory documents effortlessly.

    Recall Management

    Get real-time tracking and intelligent follow-up forms through Smarteeva’s exclusive platform.

    MDREngine

    Access detailed medical device safety data from MAUDE, Recalls, Warning Letters, FAERS, and beyond.

    Case Study

    Scalable Complaint Management with Cost Benefits

    A top producer of glucose monitoring systems required a robust system for post-market surveillance and complaint management, handling 3 million complaints and 300,000 MDRs annually. Smarteeva stepped in to provide a scalable, unified solution that addressed their high-volume challenges.

    Smarteeva simplified product registration and tracking

    A global medical technology company required a streamlined digitized system for speedy product registration, product status, expiration date tracker, Country requirement group all together. The company manufactured both diagnostic and therapeutic products that made tracking the entire product portfolio in a single application a challenge for the customer along with cost and time maintenance.

    Data Sheet

    Simplify PMS Reporting with Smarteeva

    With Smarteeva’s Post-Market Surveillance (PMS) reporting, medical device safety and performance are continuously monitored. Beyond meeting regulatory requirements, our system helps improve device quality by generating key reports such as PSUR, PMSR, HCSR, PMPF-ER, and PMCF-ER. The platform simplifies report planning, grouping licensed products for efficient and organized submissions.

    FDA Data at your fingertips with Smarteeva’s MDREngine

    By leveraging Smarteeva’s organized and enriched data lake, Medical Device companies can simplify research, literature reviews, and compliance reporting, reducing data collection and analysis time by hundreds of hours each year.