# smarteeva.com

> AI-optimized mirror of smarteeva.com containing 51 pages totalling 56,105 words of clean markdown content, structured data, and semantic HTML. Original source: https://smarteeva.com/. Last updated: 2026-06-11T01:52:20.855Z.

Each page is available as HTML (with JSON-LD structured data) and Markdown (text-only, ideal for LLMs and RAG).

## Homepage

- [site-root.html](/content/site-root.html) (1 words)

## Articles & Blog Posts

- [solutions/fda-submission-automation/index.html](/content/solutions/fda-submission-automation/index.html)
- [How Smarteeva Closes the Recall Management Gap Between Manufacturers and Healthcare Providers](/content/blog/recall-management-gap-between-manufacturers-and-healthcare-providers.html): Smarteeva has spoken directly with healthcare provider organizations about how they handle recall notifications from medical device manufacturers. The findings point to a system that is failing at almost every step. Hospitals receive multiple recall notices every day. The departments managing them are understaffed and receive no additional reimbursement. The notices themselves are often misdirected, duplicated, incomplete, or impossible to reconcile with actual inventory. What should be a straightforward safety process has become an operational burden that consumes hours of staff time and still leaves gaps. (1,331 words)
- [How Smarteeva Enables Proactive Post-Market Surveillance with Real-World Data](/content/blog/how-smarteeva-enables-proactive-post-market-surveillance-with-real-world-data.html): For decades, post-market surveillance has worked like firefighting. A complaint arrives. An adverse-event report is filed. Quality and regulatory teams scramble to limit the damage. That model is breaking. The volume, variety, and velocity of real-world data from electronic health records, service logs, registries, and social channels now let manufacturers spot weak signals long before patients are harmed or brands are damaged. Regulators on both sides of the Atlantic are encouraging this shift. Smarteeva was built for it. (1,338 words)
- [Smarteeva Solves High-Volume Complaint Handling for a Leading Glucose Monitoring Company](/content/case-studies/dexcom-high-volume-complaints/index.html): Smarteeva is scalable with no noticeable loss in system responsiveness even after 3 million annual complaints and over 165 million Audit Trail entries. (416 words)
- [How Smarteeva’s UI/UX Design Reduces Training Costs and Complaint Handling Time](/content/blog/how-smarteeva-ui-ux-reduces-training-costs-complaint-handling.html): The medical device industry runs on software that was designed for compliance, not for the people who use it. Most quality management systems prioritize feature checklists over usability. The result: long training cycles, high error rates, and quality teams that fight the tool instead of using it. Smarteeva was built with a different assumption. A well-designed interface is not a nice-to-have. It is a strategic advantage that directly affects complaint handling speed, accuracy, and team adoption. (534 words)
- [How Smarteeva Automates Medical Device Complaint Intake From Email, Forms, and Bulk Files](/content/blog/how-smarteeva-automates-medical-device-complaint-intake.html): Complaint intake is the first step in every post-market surveillance workflow, and at most manufacturers it is still entirely manual. A Quality team member opens an email from a distributor, reads through three paragraphs to find a lot number, copies 14 fields into an eQMS, and hopes nothing was transposed. At 200+ complaints per month, this process consumes one or more full-time employees doing work that has nothing to do with investigation, root cause analysis, or patient safety. Smarteeva replaces that manual extraction with an AI-powered intake engine that reads unstructured complaint sources, accepts submissions from web forms and connected systems, creates structured records enriched with CRM and device data, and detects duplicates before a single field is entered by hand. (2,127 words)
- [eQMS vs Post-Market Surveillance Platform: What MedTech Teams Get Wrong About This Decision](/content/blog/eqms-vs-post-market-surveillance-platform/index.html): When a medical device company outgrows spreadsheets and starts looking for complaint management software, the first category they land on is usually eQMS. Electronic Quality Management Systems handle SOPs, training records, design controls, and audit management. They also claim to handle complaints. The problem is that handling complaints and handling post-market surveillance are fundamentally different jobs that require different architectures. An eQMS stores complaints as quality events. A purpose-built PMS platform turns complaint data into regulatory submissions, safety reports, recall workflows, and signal detection. The difference matters because it determines what your team can do with complaint data after it enters the system. (1,802 words)
- [Transform How Complaints and Adverse Events Are Handled](/content/platform/complaints-management/index.html): Smarteeva's AI-driven complaint management automates intake, risk assessment, investigation, and regulatory reporting for medical device companies. Built on Salesforce. (1,075 words)
- [How Smarteeva Automates IMDRF Code Assignment in Medical Device Complaint Workflows](/content/blog/how-smarteeva-automates-imdrf-code-assignment/index.html): IMDRF codes are the classification layer that connects complaint records to trend analysis, regulatory reports, and signal detection. When the codes are wrong, everything built on top of them is wrong: the trend data is unreliable, the regulatory submissions are miscategorized, and the safety signals that should trigger investigation are buried in noise. Most manufacturers assign IMDRF codes manually, one complaint at a time, using human judgment against a taxonomy of hundreds of codes across seven annexes. Smarteeva suggests codes at the point of intake using AI, ranks them by confidence, and syncs them bidirectionally with regulatory reports so the complaint and the MDR always agree. (1,791 words)
- [blog/mit-report-95-ai-failure-medtech-different/index.html](/content/blog/mit-report-95-ai-failure-medtech-different/index.html)
- [You Were Hired to Be a Regulatory Expert. Not a Data Assembler.](/content/solutions/regulatory-affairs/index.html): Smarteeva automates MedWatch, MDR, PSUR, and global adverse event reporting , giving regulatory affairs teams time back for strategy and submission quality. (590 words)
- [The Complete Guide to MDR Reporting for Medical Devices: From Awareness to Submission](/content/blog/complete-guide-mdr-reporting-medical-devices/index.html): Medical Device Reporting is the mechanism through which regulatory authorities learn about device safety events in the real world. Under FDA 21 CFR Part 803, manufacturers must report deaths, serious injuries, and malfunctions that could lead to either. Under EU MDR Article 87, manufacturers must report serious incidents to competent authorities. Every major market has an equivalent obligation. The regulation is straightforward. The operational execution, which involves assembling data from multiple systems, writing narratives, managing multi-jurisdiction timelines, and submitting through jurisdiction-specific channels, is where manufacturers spend the most time and where the compliance risk concentrates. This guide covers every aspect of MDR reporting: who must file, what triggers a report, what goes into it, and how the submission process works. (1,886 words)
- [How Smarteeva Generates a PSUR in 8 Minutes From Connected Post-Market Data](/content/blog/how-smarteeva-generates-psur-in-8-minutes/index.html): A Periodic Safety Update Report is supposed to be a synthesis of what your post-market data tells you about a device. In practice, it is a document that takes 100 to 200 hours to produce because the data lives in five different systems and nobody has built a workflow that connects them. Quality and Regulatory teams spend weeks exporting, reconciling, calculating, formatting, and reviewing data that should have been connected from the start. Smarteeva generates the complete PSUR in 8 minutes because the data model that drives complaints, adverse events, IMDRF codes, and regulatory reports is the same model that generates the PMS report. (1,704 words)
- [Manual PMS Reporting vs Automated: What 100+ Hours of Assembly Work Actually Costs](/content/blog/manual-vs-automated-pms-reporting/index.html): There is a version of this article that opens with a statistic and tells you automation fixes everything. This is not that article. Instead, this is a side-by-side account of what manual and automated PMS reporting actually involves, step by step, so you can see where the hours go and decide for yourself whether those hours are well spent. The comparison uses a PSUR as the example because it is the most data-intensive PMS report, but the same pattern applies to PMSRs, HCSRs, and UK PSURs. (1,614 words)
- [ROI Calculator](/content/roi-calculator/index.html): Estimate how much your team can save by automating complaint intake, MDR reporting, and PSUR generation with Smarteeva. Adjust sliders for your volume and see annual savings instantly. (364 words)
- [Your Legacy QMS is holding you back. It's time.](/content/solutions/replace-legacy-qms/index.html): Move from TrackWise, MasterControl, or Veeva to a modern Salesforce-native platform, with no complex migration. Complaints, MDRs, and recalls in one system. (1,416 words)
- [Customers](/content/case-studies/index.html): See how medical device companies use Smarteeva to file 35% of FDA MDRs, resolve complaints 70% faster, and generate PSURs in 8 minutes. Real outcomes from real customers. (310 words)
- [blog/ai-effects-on-employment-yale-study-review/index.html](/content/blog/ai-effects-on-employment-yale-study-review/index.html)
- [How Smarteeva Cuts Medical Device Complaint Closure Time by 70%](/content/blog/how-smarteeva-cuts-complaint-closure-time-by-70-percent.html): The average medical device complaint takes 45 to 60 days to close. The investigation portion of that timeline is typically 10 to 18 days. The remaining 30 to 45 days are consumed by queue time between process steps: intake backlogs, IMDRF coding delays, reportability assessments waiting in someone's inbox, regulatory form assembly, and closure reviews that sit in a queue for a week. Smarteeva customers report 70% faster complaint resolution because the platform eliminates the handoff time that accounts for most of the elapsed duration, not by accelerating the investigation itself. (1,585 words)
- [Free tools for MedTech quality and regulatory teams.](/content/tools/index.html): Free tools for MedTech regulatory and quality professionals. Calculate complaint management ROI and search 181 IMDRF adverse event codes across all 7 annexes. (219 words)
- [Industry's Fastest Global Medical Recall Alerts : Designed for Health Systems](/content/platform/medtech-recalls-gateway/index.html): MedTech Recalls Gateway delivers the industry's fastest global medical recall alerts — designed specifically for hospitals and health systems. Real-time, actionable intelligence. (561 words)
- [What's happening in post-market surveillance and what to do about it.](/content/blog/index.html): Industry analysis, product updates, and practical guides for medical device quality and regulatory teams. Written by the PMS experts behind 35% of FDA MDR filings (481 words)
- [How Smarteeva’s Agentic AI Works Inside MedTech Quality Operations](/content/blog/how-smarteeva-agentic-ai-works-medtech-quality-operations.html): AI transformation has become a talking point in MedTech. But for quality and regulatory teams, the question is more specific: can AI actually work inside my processes without putting compliance at risk? The answer depends on how the AI is built, where it runs, and how much control the organization retains. Smarteeva’s Agentic AI was designed around that question. Two customers, running the same platform, arrived at two very different answers. Both of them work. (1,667 words)
- [EVENTS & CONFERENCES](/content/upcoming-events/index.html): See where Smarteeva is presenting, exhibiting, and hosting next. Past and upcoming MedTech events including The MedTech Forum, industry conferences, and webinars. (205 words)
- [Privacy Policy](/content/legal/index.html): Smarteeva's privacy policy, terms of use, and data handling practices. Smarteeva is SOC 2 Type II certified, HIPAA eligible, and 21 CFR Part 11 compliant. (1,456 words)
- [Quality Management That Runs Where Your Business Runs : On Salesforce](/content/solutions/salesforce-quality-management/index.html): Smarteeva is 100% Salesforce-native quality management for medical devices. Complaints, adverse events, PMS reporting, and recalls — on the platform you already trust. (854 words)
- [What's happening in post-market surveillance and what to do about it.](/content/downloads/index.html): Download product datasheets, white papers, and implementation guides for AI-powered complaint management, adverse event reporting, and post-market surveillance. (124 words)
- [platform/adverse-events/index.html](/content/platform/adverse-events/index.html) (1 words)
- [Your Complaint Volume Is Growing. Your Team Isn't. Now What?](/content/solutions/post-market-surveillance/index.html): Scale your post-market surveillance without scaling your team. Smarteeva's AI platform automates complaints, adverse events, PMS reporting, and recalls — 40% faster. (1,016 words)
- [IMDRF Code Lookup Tool - Free, Searchable, All 7 Annexes](/content/imdrf-codes/index.html): Free IMDRF adverse event terminology code lookup. Search and browse 181 codes across all 7 annexes: Device Problem, Patient Problem, Component, Cause Investigation, Health Effect, Investigation Type, and Findings. No login required. (11,527 words)
- [From 2.6 Million MDRs to Actionable Insight: How AI Is Changing Post-Market Surveillance](/content/blog/how-ai-is-changing-post-market-surveillance-medtech.html): In 2024, the FDA received 2.6 million Medical Device Reports from manufacturers worldwide. Add 102 FDA recalls, millions of customer calls, data from over 100,000 installed platforms, scientific literature, clinical studies, and quality management systems, and the picture becomes clear: the volume of post-market data has outgrown every manual process built to handle it. At the MedTech Forum in Lisbon, one of Smarteeva’s customers (a global leader in in-vitro diagnostics and medical device manufacturing) presented how they are using AI to turn that data flood into real-time product intelligence. This is what that transformation looks like in practice. (1,088 words)
- [How Smarteeva Identified the Top 5 Trends Reshaping Post-Market Surveillance](/content/blog/how-smarteeva-identified-the-top-5-trends-reshaping-post-market-surveillance.html): At Smarteeva, we work with medical device companies across the globe and pay close attention to where their processes and investments are heading. Most devices in the field are mature products. But the infrastructure around them is changing fast. Newer technologies are opening up real possibilities for better process adherence, operational efficiency, and patient safety. These are the five trends we see gaining the most traction. (698 words)
- [Smarteeva Orchestra: Your Team Builds the AI. No Code. No Data Scientists.](/content/platform/ai-automation/index.html): Automate complaint intake, adverse event detection, and regulatory reporting with AI. Built for FDA & EU MDR compliance. Trusted by 450+ MedTech companies. (2,532 words)
- [One Platform. Every Post-Market Workflow. AI Across Everything.](/content/platform/index.html): Unified platform for complaints, adverse events, PMS, and recalls. Salesforce-native, AI-powered, and built for regulated MedTech environments. (1,138 words)
- [Automated Post-Market Surveillance Reporting : From 100+ Hours to Just 8 Minutes](/content/platform/pms-reporting/index.html): Smarteeva automates EU PSUR, UK PSUR, PMSR, PMPF-ER, and HCSR generation — from 100+ hours to 8 minutes. AI-powered PMS reporting for medical device companies. (766 words)
- [FDA Data at Your Fingertips - MDRs, Warning Letters, Recalls, and FAERs](/content/platform/mdrengine/index.html): MDREngine aggregates, cleans, and correlates FDA data — MDRs, FAERs, recalls, warning letters, clinical studies — for faster competitive research and regulatory reporting. (580 words)
- [How Smarteeva Submits an MDR to the FDA in 3 Minutes via ESG NextGen API](/content/blog/how-smarteeva-submits-mdr-to-fda-in-3-minutes/index.html): Medical Device Reporting is the most time-sensitive obligation in post-market surveillance. Under 21 CFR Part 803, manufacturers must report deaths, serious injuries, and certain malfunctions to the FDA within 30 calendar days or 5 business days, depending on severity. The regulation is clear. The operational reality is that most manufacturers take 5 to 15 business days to assemble and submit a single report because the data lives across three or four different systems and no one owns the end-to-end process. 35% of all Medical Device Reports submitted to the FDA are filed through Smarteeva. Average submission time: 3 minutes. (1,895 words)
- [AI in Post-Market Surveillance: What Actually Works and What Is Still Marketing](/content/blog/ai-in-post-market-surveillance-what-actually-works/index.html): Every post-market surveillance vendor now claims to use AI. The word appears on landing pages, in demo environments, and in conference presentations. Most of the time it describes a feature that was added to check a box rather than a capability that changes how work gets done. This matters because Quality and Regulatory teams are being asked to evaluate AI claims they have no framework to verify. When a vendor says "AI-powered complaint management," that could mean a rules engine with a marketing label or a system that reads unstructured emails and creates complete complaint records in 60 seconds. This post separates what AI actually does in post-market surveillance today, in production, at scale, from what remains theoretical or experimental. (1,702 words)
- [Frequently Asked Questions](/content/faq/index.html): Answers on Smarteeva pricing, data security, Salesforce integration, implementation timelines, and how Smarteeva compares to legacy QMS vendors like Veeva and MasterControl. (1,174 words)
- [Finally, a Quality System That Runs on Your Platform](/content/solutions/salesforce-admins/index.html): Smarteeva runs 100% natively on Salesforce. Configure quality management workflows, decision trees, and reports using the standard Salesforce tools you already know. (788 words)
- [End-to-End Recall Management : From Decision to Resolution](/content/platform/recall-management/index.html): Smarteeva's recall management system automates notification, approval, follow-up, and tracking for medical device recalls. Built on Salesforce with a dedicated recall portal. (495 words)
- [Every Complaint. Every Channel. One Platform.](/content/solutions/unified-complaint-intake/index.html): Stop managing complaints across email, phone, portals, and spreadsheets. Smarteeva unifies every complaint channel into one AI-powered platform on Salesforce. (910 words)
- [Tutorials & Documentation](/content/utility/tutorials/index.html): A modern SaaS website template built for AI and software products, with multiple homepage layouts, product pages, and conversion-focused sections., Watch a step-by-step walkthrough of building a new platform page in Webflow. Learn how to efficiently format content, structure layouts, and generate schema markup in under 15 minutes., Learn how to manage and publish content using the Webflow CMS. This guide covers the difference between static and dynamic content, how to edit elements on the page, and how to configure buttons for video integration., This video covers the various methods for creating new pages, whether you are starting from scratch or utilizing existing templates., Learn how to edit your navigation bar in Webflow by accessing the master component. This tutorial guides you through switching roles, selecting the navigation element, and updating dropdown links., Learn how to create and link new industry pages for your website using the marketer role. This tutorial walks you through setting up templates, publishing pages, and updating your navigation bar., Learn how to efficiently import bulk CMS items by exporting your current structure first to ensure compatibility. This guide covers the import process, field mapping, and handling thumbnails for your new content., Learn how to embed an ROI calculator script into your page using the code embed feature. This guide covers the necessary steps from pasting the script to testing on staging before publishing to production. (147 words)
- [What to expect from your demo](/content/demo/index.html): See how our AI streamlines complaint intake, regulatory submissions, and investigations. 30-minute personalized demo tailored to your team and markets. (305 words)
- [sitemap-xml.html](/content/sitemap-xml.html) (74 words)
- [How Smarteeva Automates PMCF Reporting Under EU MDR](/content/blog/how-smarteeva-automates-pmcf-reporting-under-eu-mdr.html): Post-Market Clinical Follow-Up is one of the most documentation-heavy requirements in EU MDR. It demands continuous collection and analysis of clinical data across a device’s entire market life, covering everything from user surveys and patient registries to adverse event tracking and literature reviews. Most teams manage this process manually, pulling data from disconnected systems and assembling reports by hand. Smarteeva turns that process into an automated workflow where data aggregation, analysis, and report generation happen inside a single platform. (1,438 words)
- [Your Team Is Too Talented to Spend Their Time on Data Entry](/content/solutions/quality-leaders/index.html): Smarteeva gives quality leaders real-time visibility into complaints, adverse events, investigations, and quality trends — with AI that makes your team 40% faster. (886 words)
- [Infusion Pumps & the Global Crisis: A Smarteeva Perspective](/content/blog/infusion-pump-recall-crisis-baxter-bd-smiths-medical.html): Infusion pumps deliver fluids at automated intervals, and the demand for safer, patient-focused devices has never been higher. But the infusion pump market has been troubled by a pattern of security concerns and product recalls that spans multiple manufacturers. Baxter, Becton Dickinson, and Smiths Medical have all issued significant recalls in recent years. The pattern is not isolated to one company or one product line. It points to systemic quality challenges across the device category. (746 words)
- [We didn't start in MedTech.  _That's exactly why we saw what everyone inside it had stopped noticing._](/content/about/index.html): Purpose-built AI platform for medical device post-market surveillance. Trusted by 450+ MedTech companies. MDR submissions in 3 minutes, PSURs in 8. (594 words)
- [Our offices](/content/contact/index.html): Reach out to Smarteeva's offices in the US, Europe, or Asia. Contact our team for AI-powered post-market surveillance solutions. (154 words)

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