Streamline post market surveillance by searching and analyzing the FDA, MHRA, and global healthcare authorities at once.
Learn how you can automate adverse event reporting, proactively identify preventative actions to implement to avoid recalls, and gather all the information you need about comparable medical devices and drugs with a single click of a button.
Find and analyze all the adverse event reports you need in one easy to use platform
The need for comprehensive and effective post market surveillance (PMS) is business critical. But the information you need is scattered across multiple databases. How can you streamline this process?
Foundation, ResoluteAI's scientific discovery engine, lets you conduct research across multiple FDA and MHRA databases simultaneously. Combined with our interactive analytics and downloadable visualizations, you can:
+ Analyze adverse events and recalls in minutes
+ Discover information on comparable devices faster
+ Eliminate repetitive work with saved searches and proactively monitor the latest reports
"I love using ResoluteAI to search multiple brand names, or Product Codes, to search our products alongside comparable products...We can now do this in minutes with Foundation."
Connected healthcare authority datasets include:
Clinical trials Aggregated, global clinical trial information from ClinicalTrials.gov, EU CTR, ANZCTR, and more.
FDA 510(k) Premarket notifications by a company that they intend to market a medical device, which must be filed 90 days prior to the device being marketed.
FDA Classifications Medical devices grouped into regulatory classes based on intended use and indications for use.
FDA Device recalls Medical device correction or removal actions initiated by a firm prior to review by the FDA.
FDA Drug adverse events Adverse event and medication error reports associated with the use of a drug or biologic product. (FAERS)
FDA Drugs Information about drugs, including biological products, approved for human use in the United States.
FDA MAUDE Medical device reports (MDRs) submitted to the FDA by mandatory and voluntary reporters. One of the FDA's several important postmarket surveillance data sources.
FDA Premarket approval Evaluation of the safety and effectiveness of Class III medical devices.
FDA Registrations and listings Locations of medical device establishments and the devices manufactured there.
FDA Unique device identifier Unique codes consisting of device identifiers and production identifiers to help with electronic tracking for devices involved in adverse events.
MHRA Aggregated data from the UK's Medicines and Healthcare products Regulatory Agency that ensures medical devices, medicines, and blood for transfusions meet standards.
News Aggregated business news from thousands of global sources with a focus on science, technology, quality, regulations, and medical legislation.
Data analytics Visualize known product problems and outcomes by manufacturer and brand. There are a variety of chart options including line, bar, area, and spline charts along with tree maps, Sankey diagrams, and the ResoluteAI Network Graph.
Proactive surveillance Eliminate repetitive work with saved searches delivering the latest FDA and MHRA entries directly to your inbox.
Easily share research Results from all datasets, from the FDA and MHRA, can be easily exported for analysis data outside of the ResoluteAI platform.
"Post-market surveillance is forced to use clunky databases like FDA MAUDE, which is really limiting. It requires a lot of time to gather and analyze data. I love using ResoluteAI to search multiple brand names, or Product Codes, to search our products alongside comparable products. The heatmap gives me a crisp view of the data, common product problems we should be mindful of, and we can export up to 5000 records at a single time to create meaningful reports for submission. This kind of work used to take a full day, or sometimes more, to complete. We can now do this in minutes with Foundation."
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"... a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have been placed on the market, and to identify the need to take any action. Post-market surveillance is a crucial tool to ensure that medical devices continue to be safe and well-performing and to ensure actions are undertaken if the risk of continued use of the medical device outweighs the benefit. The evaluation of post-market surveillance experiences can also highlight opportunities to improve the medical device. "
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