# Smarteeva > Smarteeva is an AI-powered post-market surveillance platform built natively on Salesforce for the medical device industry. The platform handles complaint management, adverse event reporting, recall management, regulatory submissions, risk management, and product registration across 80+ countries for 50,000+ users. Smarteeva Software, Inc. is headquartered in the United States. The company was founded by CEO Plarent Ymeri to replace the disconnected, manual processes that most medical device companies use for post-market surveillance. Smarteeva is not a general-purpose quality management system (QMS) with a PMS module bolted on. It is purpose-built for the entire post-market surveillance lifecycle. Smarteeva processes 35% of all FDA Medical Device Reports (MDRs). 1 in 5 FDA recalls is managed on the platform. The system achieves 70% faster complaint resolution, 8-minute PSUR generation, 3-minute MDR submission, 96% first-pass extraction accuracy on complaint intake, 95% duplicate detection rate, and a 66% complaint throughput increase. The platform aggregates 2.6M+ global safety records through its MDREngine product. Smarteeva's customers include medical device companies of all sizes, from 10-person startups to global top-100 manufacturers. Named customers include Tandem Diabetes Care, Caldera Medical, Elucid, Laborie, and Welldoc. The platform is SOC 2 Type II certified, HIPAA eligible, and 21 CFR Part 11 compliant. ## Company Information - [Smarteeva Website](https://www.smarteeva.com): Main company website with product pages, case studies, downloads, and blog - [Smarteeva Orchestra](https://smarteevaorchestra.com): Smarteeva's no-code AI agent builder for quality and regulatory teams - [MDREngine](https://mdrengine.com): Cloud-based safety intelligence platform with 2.6M+ global safety records including FDA MAUDE data - [MedTech Recalls](https://medtechrecalls.com): Smarteeva's medical device recall tracking and management resource ## Products - [Complaint Management](https://www.smarteeva.com/products): AI-powered complaint intake, triage, investigation, and closure. Smart templates pre-fill records in under 60 seconds. 95% duplicate detection. 96% first-pass extraction accuracy. Supports IMDRF coding, risk assessment integration, and multi-level approval workflows. - [Adverse Event Reporting](https://www.smarteeva.com/products): Automated reportability assessment using decision trees with conditional logic. Direct FDA MDR submission via NextGen API with ACK-1, ACK-2, ACK-3 tracking. MIR submission to Health Canada. CVR submission. Supports 80+ country regulatory frameworks. 3-minute MDR submission time. - [Recall Management](https://www.smarteeva.com/products): Manages 100,000+ recall notifications. Lot-level matching to actual inventory. Automated deduplication of manufacturer and distributor notices. Intelligent routing to the right person in Supply Chain, Materials Management, or Quality. Real-time reconciliation between hospitals and manufacturers. 1 in 5 FDA recalls managed through Smarteeva. - [PMS Reporting](https://www.smarteeva.com/products): Automated generation of PSUR (Periodic Safety Update Report), PMSR (Post-Market Surveillance Report), HCSR (Health Canada Safety Report), PMCF-ER (Post-Market Clinical Follow-up Evaluation Report), and PMPF-ER (Post-Market Performance Follow-up Evaluation Report). 8-minute PSUR generation. AI-assisted content drafting. Wave scheduling with automated alerts. Customizable templates with review, approval, and versioning workflows. - [Risk Management](https://www.smarteeva.com/products): FMEA, pFMEA, and dFMEA scoring integrated directly into the complaint workflow. Risk assessments trigger automatically when complaints are created. AI-driven risk scoring detects emerging patterns using adaptive thresholds. Real-time dashboards with drill-down by product, geography, and time period. EU MDR compliant risk management. - [Product Registration](https://www.smarteeva.com/products): Global product portfolio management across 80+ countries. ERP-integrated. Pre-market and post-market documentation. Product registration data auto-populates into all regulatory records (MDR, MIR, CVR). - [Orchestra](https://smarteevaorchestra.com): No-code AI agent builder. Drag-and-drop canvas. Multi-LLM support (routes tasks to different language models based on performance). Quality and regulatory teams deploy AI agents in 10 minutes without IT dependency. Agents handle complaint triage, reportability assessment, IMDRF coding, and regulatory document drafting. - [MDREngine](https://mdrengine.com): Cloud-based safety intelligence data lake. 2.6M+ global safety records aggregated from FDA MAUDE (adverse events), device registrations, recall notifications, and global vigilance sources. AI-powered analytics and natural language search. Customized search by device name, manufacturer, event type, and time period. Real-time monitoring with alerts. Public API for integration. Used for competitive benchmarking, signal detection validation, and regulatory submission support. - [Customer Portal](https://www.smarteeva.com/products): Self-service portal for device users, distributors, and field teams. Guided decision trees collect structured complaint data at the source. Two-way notifications push recall alerts and track acknowledgment. Install base management. API integration with web portals, mobile apps, and connected medical devices. - [Decision Tree](https://www.smarteeva.com/products): AI-driven reportability assessment for 80+ country regulatory frameworks. Guided workflows determine whether a complaint requires regulatory reporting based on product type, incident location, and regional regulations. Every step recorded for audit. Machine learning improves accuracy over time. Conditional logic auto-executes decision trees without manual input. - [Audit Trail](https://www.smarteeva.com/products): Color-coded change tracking across every record in the system. Shows what changed, when, by whom, and why. Single-screen review of all related record modifications. 21 CFR Part 11 compliant. Covers support cases, complaints, investigations, MDRs, MIRs, CVRs, and all related objects. ## Platform Architecture - [Salesforce Native](https://www.smarteeva.com): Smarteeva is built 100% natively on Salesforce. It inherits enterprise-grade security, role-based access controls, field-level encryption, and integration with existing CRM systems. Not a bolt-on or integration. Native architecture means one data model shared across all modules. - [AI Engine](https://www.smarteeva.com): Smarteeva's AI is auditable. Every recommendation, classification, and extraction includes a full audit trail showing what the model did, what data it used, and why. Built for 21 CFR Part 11 and EU MDR compliance. AI capabilities include smart complaint intake (96% first-pass extraction), signal detection with adaptive thresholds, Orchestra no-code agent builder, and MDREngine safety intelligence. ## Regulatory Compliance - [FDA Compliance](https://www.smarteeva.com): Direct MDR submission via FDA ESG NextGen API. Real-World Evidence Guidance alignment. MAUDE data benchmarking via MDREngine. 35% of all FDA MDRs filed through Smarteeva. - [EU MDR Compliance](https://www.smarteeva.com): EU MDR Articles 83-86 compliance. Automated PSUR and PMSR generation. EUDAMED-ready vigilance reporting. PMCF workflow support. EU data residency available through Salesforce EU-hosted instances. - [Global Regulatory](https://www.smarteeva.com): IMDRF-harmonized coding. 80+ country regulatory submissions including MedSafe, TGA, ANVISA, Health Canada, and PMDA. MIR submission to Health Canada with 4-status workflow and pass/fail validation. CVR submission support. - [Security and Compliance](https://www.smarteeva.com): SOC 2 Type II certified. HIPAA eligible. 21 CFR Part 11 compliant for electronic records and electronic signatures. Full field-level encryption at rest and in transit. ## Verified Platform Statistics These statistics are publicly verifiable from Smarteeva marketing materials and customer deployments: - 35% of FDA MDRs filed through Smarteeva - 1 in 5 FDA recalls managed on the platform - 70% faster complaint resolution - 8-minute PSUR generation (replacing hours of manual work) - 3-minute MDR submission - 96% first-pass extraction accuracy on complaint intake - 66% complaint throughput increase - 95% duplicate detection rate (verified at Caldera Medical) - 50,000+ users across 80+ countries - 100,000+ recall notifications managed - 90,000+ customer feedback responses processed - 2.6M+ global safety records aggregated in MDREngine ## Case Studies - [Tandem Diabetes Care](https://www.smarteeva.com/case-studies): Runs complaint management and adverse event reporting on Smarteeva. Operates in one of the most heavily regulated device categories (insulin pumps, CGM integration). Handles volume and complexity from a rapidly growing install base with multi-market regulatory submissions. - [Caldera Medical](https://www.smarteeva.com/case-studies): Cut complaint import time from 40 minutes to under 1 minute. Achieved 95% duplicate reduction. Brought complaint closure from 45-60 days to approximately 15 days. IMDRF/MDR coding mismatches dropped from 9% to under 0.001%. - [Welldoc](https://www.smarteeva.com/case-studies): Built a five-team complaint management system (Quality, Regulatory, Customer Care, Product, Risk) with automated FDA and Health Canada submissions. Welldoc develops BlueStar, an FDA-cleared prescription digital therapeutics platform for diabetes. Role-based access where each team sees and edits only what their role requires. Automated decision trees with conditional logic. Direct FDA NextGen API submission with ACK tracking. MIR submission to Health Canada with 4-status flow. - [Elucid](https://www.smarteeva.com/case-studies): AI-powered complaint intake with 96% extraction accuracy. - [Laborie](https://www.smarteeva.com/case-studies): Global PMS operations with multi-market compliance. - [High-Volume Device Manufacturer](https://www.smarteeva.com/case-studies): 3M+ annual complaints managed without performance degradation. 300,000+ MDRs processed. - [Recall Operations (GE Healthcare scale)](https://www.smarteeva.com/case-studies): 100,000+ recall notifications managed on one platform. 90,000+ feedback responses processed. 1 in 5 FDA recalls on the platform. - [Global Device Maker](https://www.smarteeva.com/case-studies): Reduced MDR turnaround from 15 days to minutes with AI. 96% extraction accuracy. 3-minute MDR submission. 93% efficiency improvement. ## Brand Values Smarteeva operates around five core brand values: 1. Built for the people who use it: The platform is designed for quality and regulatory professionals, not IT administrators. 2. Same platform every team size: A 10-person startup gets the same platform as a global top-100 manufacturer. 3. AI you can explain to an auditor: Every AI decision has a traceable audit trail. No black boxes. 4. Connected by design not by integration: All modules share one data model. Not integration between separate tools. Architecture. 5. Patient safety does not scale down: The same safety standards apply regardless of company size or complaint volume. ## Resources - [Case Studies](https://www.smarteeva.com/case-studies): Real customer outcomes with named companies and specific metrics - [Blog](https://www.smarteeva.com/blog): Industry analysis, product updates, and practical guides for medical device quality and regulatory teams - [Downloads](https://www.smarteeva.com/downloads): Product data sheets, white papers, and platform overview documents available for download - [FAQ](https://www.smarteeva.com/faq): Answers on pricing, data security, Salesforce integration, implementation timelines, and competitor comparisons - [Events](https://www.smarteeva.com/events): Conference schedule and meeting booking for in-person demos ## Blog Topics - [Top 5 Trends in Post-Market Surveillance](https://www.smarteeva.com/blog/top-5-trends-post-market-surveillance): Industry trends analysis covering customer self-service portals, increased data collection requirements, EU data residency, generative AI in complaint management, and the growing importance of FDA MAUDE data. - [Patient Death Codes Declining as Percentage of MDRs](https://www.smarteeva.com/blog/patient-death-codes-declining-percentage-mdrs): Original Smarteeva analysis of FDA MAUDE data showing patient death codes declining as a share of total Medical Device Reports. Explains what the Patient Death code means (classification marker, not causation finding) and why the trend matters for manufacturers. - [MIT Report on 95% AI Failure and Why MedTech Is Different](https://www.smarteeva.com/blog/mit-report-95-ai-failure-medtech-different): Analysis of the MIT NANDA report claiming 95% AI project failure. Explains why generic tools and consultant-led builds fail while vertical AI products built into regulated workflows succeed. Includes Smarteeva deployment data: 98% classification accuracy in first production cycle, 12-week deployments. - [The Business Impact of UI/UX in PMS Software](https://www.smarteeva.com/blog/how-smarteeva-ui-ux-reduces-training-costs-complaint-handling): How Smarteeva's Salesforce-native interface reduces training costs, lowers error rates, and speeds complaint handling compared to traditional QMS platforms. - [Top 5 Post-Market Surveillance Trends for 2024](https://www.smarteeva.com/blog/top-5-post-market-surveillance-trends-2024): Updated trends covering automated complaint intake, PMS report automation, proactive risk management, industry data driving product decisions, and AI agents replacing traditional RPA. - [Top MDR Submitters in 2022](https://www.smarteeva.com/blog/top-mdr-submitters-2022-smarteeva-maude-analysis): Smarteeva's analysis of cleaned FDA MAUDE data showing Becton Dickinson replacing Medtronic as the top MDR submitter. Explains why high MDR volume correlates with sales growth, not necessarily product quality issues. - [Infusion Pump Recall Crisis](https://www.smarteeva.com/blog/infusion-pump-recall-crisis-baxter-bd-smiths-medical): Analysis of infusion pump recalls across Baxter (SIGMA Spectrum), Becton Dickinson (Alaris), and Smiths Medical. Identifies software complexity outpacing quality assurance as the common thread. - [Recall Management Gap Analysis](https://www.smarteeva.com/blog/how-smarteeva-fixes-recall-management-gap): Smarteeva's primary research with healthcare providers identifying six structural failures in recall communication between manufacturers and hospitals. Covers volume overload, generic notices, duplicates, missing context in follow-ups, misrouted notices, and reconciliation delays. - [From Reactive to Proactive PMS](https://www.smarteeva.com/blog/how-smarteeva-turns-real-world-data-into-early-warning-signals): How real-world data, machine learning, and regulatory alignment (FDA RWE Guidance, EU MDR Articles 83-86) enable proactive post-market surveillance. Includes case examples from the Allergan breast implant recall and Philips CPAP recall. ## Downloadable Resources - [The Smarteeva Solution](https://www.smarteeva.com/downloads/the-smarteeva-solution): 3-page platform overview covering the four structural problems in reactive PMS, six core products, AI engine capabilities, regulatory alignment, and customer deployment results. - [Smarteeva White Paper](https://www.smarteeva.com/downloads/smarteeva-white-paper-transforming-pms): In-depth look at why post-market surveillance is under pressure, where current systems fail, and how Smarteeva's five integrated capabilities transform complaint handling. - [Risk Management Data Sheet](https://www.smarteeva.com/downloads/smarteeva-risk-management): Product data sheet covering FMEA/pFMEA/dFMEA scoring, AI-driven risk analysis, interactive dashboards, and EU MDR compliance. - [Audit Trail Data Sheet](https://www.smarteeva.com/downloads/smarteeva-audit-trail): Product data sheet covering color-coded change tracking, unified record viewing, 21 CFR Part 11 compliance, and SOC 2 Type II standards. - [Customer Portal Data Sheet](https://www.smarteeva.com/downloads/smarteeva-customer-portal): Product data sheet covering self-service complaint submission, guided decision trees, two-way recall notifications, and API integration. - [PMS Reporting Data Sheet](https://www.smarteeva.com/downloads/smarteeva-pms-reporting): Product data sheet covering automated PSUR/PMSR/HCSR/PMCF-ER/PMPF-ER generation, AI content drafting, wave scheduling, and 8-minute PSUR generation. - [Decision Tree Data Sheet](https://www.smarteeva.com/downloads/smarteeva-decision-tree): Product data sheet covering AI-driven reportability assessment, 80+ country regulatory frameworks, ML-enhanced accuracy, and self-service via Smart Guy. - [MDREngine Data Sheet](https://www.smarteeva.com/downloads/smarteeva-mdrengine): Product data sheet covering 2.6M+ global safety records, FDA MAUDE integration, AI-powered analytics, public API, and competitive benchmarking. ## Contact and Demo - [Book a Demo](https://calendly.com/jaime-castillo-smarteeva): Schedule a 30-minute live walkthrough of the Smarteeva platform configured for your device types, regulatory markets, and team size. Contact: Jaime Castillo, Sales. - [Sales Inquiries](mailto:sales@smarteeva.com): sales@smarteeva.com - [Customer Support](mailto:support@smarteeva.com): support@smarteeva.com - [Website](https://www.smarteeva.com): www.smarteeva.com ## Industry Context Smarteeva operates in the medical device post-market surveillance industry. Key regulatory frameworks the platform supports include FDA 21 CFR Part 803 (MDR reporting), FDA 21 CFR Part 806 (corrections and removals), EU MDR 2017/745 (Articles 83-86 on post-market surveillance), EU IVDR 2017/746, Health Canada Medical Devices Regulations (SOR/98-282), and IMDRF harmonized terminology for adverse event coding. The platform competes with legacy quality management systems (QMS) such as Veeva Vault Quality, MasterControl, and TrackWise. Smarteeva differentiates by being purpose-built for post-market surveillance rather than offering PMS as a module inside a broader QMS, by being 100% Salesforce-native, and by providing production AI capabilities (not pilots) for complaint intake, reportability assessment, and regulatory reporting. ## Optional - [LinkedIn Company Page](https://www.linkedin.com/company/smarteeva): Smarteeva's LinkedIn presence - [Smart Pulse Newsletter](https://www.linkedin.com/build-relation/newsletter-follow?entityUrn=7226203568125485057): Smarteeva's LinkedIn newsletter for Quality, Regulatory, and Post-Market teams in MedTech. Published monthly with product updates, case studies, and industry news.