THE OVERVIEW
PSURs play an essential role in tracking the safety of medical devices. EU MDR/IVDR mandates that a PSUR provide a summary of significant findings and actions from post-market surveillance data for each medical or in vitro diagnostic device (IVD), documenting all preventive and corrective actions throughout the product’s lifecycle, even beyond its market presence.
PSURs are designed to capture both current and emerging information on a product’s benefit-risk profile. A typical PSUR includes data from non-clinical studies, surveillance systems, usage data, patient programs, clinical trials, and scientific literature. This extensive information, sourced from reputable research networks and industry partnerships, ensures a complete safety and efficacy assessment.
FEATURES
- One-Click Report Generation
- Direct PSUR Report Submission to Regulatory Authorities. Auto-Populate Data Fields
- Quick content review for report completeness
- Integrated analytics on ERP, sales, complaints, and risk.
- Timely vigilance reporting in line with local regulations.
- Unified data collection from multiple sources for accuracy.
THE SMARTEEVA DIFFERENCE
- Smarteeva employs proven technology from Complaints, MIRs, MDRs, and Risk Management to make PSUR generation quicker, more secure, and fully automated.
- By incorporating recent safety data alongside cumulative findings, Smarteeva’s technology enables PSURs to offer a more detailed analysis of product risks and benefits for improved decision support.
- Smarteeva supports literature search and analysis through careful refinement and finalization of search criteria.
- Smarteeva allows users to design Structured Templates for PSURs.
- PSURs involve data from multiple products and issues, including sales metrics. Smarteeva consolidates all this information, enabling users to produce a full report in one click.
- The Smarteeva system integrates data aggregation tools, allowing users to efficiently search, filter, and access information for streamlined PSUR completion.
- With advanced analytics across ERP, sales, complaints, and risk management data, Smarteeva allows users to drill down effortlessly, streamline regulatory report preparation, and prioritize more strategic activities.
- After PSUR creation and review, Smarteeva sends it directly to the appropriate regulatory body via automated email.
CONCLUSION
Smarteeva simplifies users’ lives by automating and accelerating the PSUR generation process, saving time and reducing complexity. Smarteeva’s technology streamlines the PSUR workflow by including essential administrative details and specific data to distinguish between different PSURs for a device. Additionally, it integrates the necessary information for EUDAMED registration, ensuring that reports meet the latest regulatory requirements.
With Smarteeva’s advanced automation, users can generate PSURs quickly and accurately, eliminating the need to navigate complex compliance requirements manually. This allows medical device manufacturers to maintain focus on innovation and patient care while staying compliant effortlessly. By using Smarteeva’s intuitive, high-quality PSUR solution, users can ensure product safety, performance, and regulatory adherence, supporting a smooth path to market success.
About Smarteeva
Based out of Santa Barbara, CA. Smarteeva Software provides cutting-edge and innovative Post Market Surveillance applications for the Medical Device industry. Smarteeva’s Complaint Handling, Adverse Event Reporting, Risk Management and Recall Management solutions prioritize compliance, organizational efficiencies and user-friendliness. Built on the Salesforce.com Platform utilizing the latest AI innovations and Machine Learning, Smarteeva Software provides a true partner to its business users.
For more information:
Reach us on : [email protected]
