Streamline your Post-Market Surveillance

Yes, we offer a Free tier that allows you to access features for searching external data sources. Additionally, there’s a14-day free trial of the Professional tier, providing full access to all platform features.

Yes, we offer an Enterprise plan for organizations that require multi-user access management, special API access, or3^rd-party integration capabilities. Please contact us for more information.

Reach out to us, and we’ll handle data collection and analysis for you, so you can concentrate on innovation and improvement. Our team specializes in extracting and analyzing data from various sources, including FDA Recall databases, MAUDE adverse event reports, BfArM, MHRA, cybersecurity data from NVD, and recent scientific literature from PubMed and ClinicalTrials.gov. We provide in-depth trend analyses, visual event graphics, and chronological event timelines to give you a comprehensive view of your device's performance and safety. With our service, you’ll receive periodic updates that enhance your Periodic Safety Update Reports (PSUR), fully aligned with your Post Market Surveillance Plan (PMSP).

PostMarketMonitor is designed to speed up the rapid review process while maintaining quality. Advanced filtering and searching features allow you to locate relevant events faster, accelerating the screening process. Additionally, our AI-based tools can pre-screen events for Use Errors, enabling efficient screening of large volumes of data.

Yes, PostMarketMonitor supports living reviews by automatically importing newly published adverse events, recalls, cybersecurity vulnerabilities, and scientific literature into your projects. Reviewers are notified of new information, and delta reports can be created to ensure no important updates are missed. These features help keep your post-market review current with the latest external data.

Studies show that 90% of spreadsheet solutions lack the comprehensive search capabilities necessary for effective post-market surveillance. These limitations, along with the time and resources needed to manage manual spreadsheets, can impact the efficiency of the review process.PostMarketMonitor is specifically designed for medical device manufacturers, addressing challenges such as growing data volumes, review bottlenecks, and regulatory requirements for transparency and auditability. By choosing PostMarketMonitorover spreadsheets, you benefit from improved efficiency, consistency, collaboration, and quality control in your reviews.

PostMarketMonitor's AI automates the labor-intensive tasks involved in reviewing data to identify Use Errors. It assists in analyzing both internal complaint data and external sources, such as FDA MAUDE, to streamline the review process.

Literature databases
Pubmed     - Literature database on medical publications Europe    
PMC – Literature database on life sciences research
Safety databases
BfArM –     Safety notices by manufacturers of medical devices in Germany
FDA  MAUDE - FDA database on Manufacturer and User Facility Device Experience
FDA Recall     - FDA database on medical device recalls
MHRA -     Alerts and recalls for medical devices United Kingdom
IT security databases
NIST NVD-     IT security database of the National Institute of Standards and     Technologies
Clinical investigation database
ClinicalTrials.gov     – Database of clinical research studies

PostMarketMonitor checks for new data daily and automatically updates your saved search results. You can receive in-app notifications and email alerts whenever there are new matching events, literature, or security vulnerabilities.

Yes, PostMarketMonitor allows you to export detailed data to Excel files. Summary reports can be exported in both Microsoft Excel and Word formats.

We take pride in listening to our customers and continuously improving PostMarketMonitor with new capabilities to enhance the review process. We aim to provide six releases each year, featuring both major new functionalities and minor feature enhancements.

Supporting our customers’ unique needs is a cornerstone of PostMarketMonitor. Our dedicated customer success team is ready to work with you to understand your specific requirements and help implement those capabilities within the PostMarketMonitor platform.

Current integration can be performed via the import and export of Excel files. Please contact our customer success team to understand your API access or integration needs.

Yes, as part of our Enterprise tier, PostMarketMonitor can configure its AI tools to screen for specific types of events or risks unique to your devices.

Yes, PostMarketMonitor is designed to help you meet post-market surveillance requirements for external data sources, including compliance with both FDA regulations in the U.S. and MDR regulations in the EU.

Choosing new software involves more than just cost. It’s about making a commitment and ensuring the platform aligns with your requirements. We offer a free 14-day trial of all our platform features, so you can explore everything firsthand. Additionally, you can schedule a demo with us, where we’ll guide you through the features and discuss how we can meet your needs.