Frequently asked questions

Smarteeva supports the major global frameworks:

• FDA 21 CFR Part 803 and Part 820
• EU MDR (including Articles 61, 84, 86, and Annex XIV Part B)
• EU IVDR
• MHRA UK MDR 2002
• Health Canada, TGA Australia, PMDA Japan, NMPA China, and ANVISA Brazil

The platform handles multi-jurisdiction routing for 80+ countries. The Smarteeva regulatory affairs team updates these requirements continuously.

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Smarteeva automates Post-Market Clinical Follow-up (PMCF) under EU MDR Article 61 and Annex XIV Part B. The workflow covers AI-generated PMCF plans, continuous real-world data intake, signal monitoring, and auto-updating PMCF evaluation reports. Every PMCF activity carries a full audit trail for notified body inspection. Read the PMCF automation walkthrough for the Article 61 mapping.

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Smarteeva is built on Salesforce, which holds FedRAMP authorization and other US federal compliance certifications. The platform supports FDA 21 CFR Part 11 compliance for electronic records and signatures. Validation documentation comes with the implementation package.

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Yes. Smarteeva is built natively on Salesforce, with Salesforce-grade security, compliance, and integration. Complaint, sales, and customer service data sit on the same data model, so no integration layer is required.

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Smarteeva runs 100% natively on Salesforce and AWS. All data sits in Salesforce's enterprise cloud, which maintains SOC 2 Type II compliance, ISO 27001 certification, HIPAA eligibility, and encryption at rest and in transit.

The platform inherits Salesforce's full security model:

• Role-based access controls
• Field-level security
• Audit trails with full traceability
• Electronic signatures (21 CFR Part 11 compliant)
• Multi-factor authentication

Smarteeva uses no proprietary database or third-party storage outside Salesforce and AWS. For data residency requirements, Salesforce offers regional data center options. Your information security team reviews one platform, not two.

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Smarteeva works with your existing systems without replacing them. Because it is built natively on Salesforce, it uses standard Salesforce APIs (REST, SOAP, Bulk, and Streaming) for integration.

Customers have connected Smarteeva to:

• ERP systems for product master data and lot tracking
• LIMS for laboratory investigation results
• Field service platforms for on-site complaint capture
• Salesforce Service Cloud, natively, with zero middleware
• Dynamics 365 CRM through API-based data exchange

No proprietary connectors or middleware licensing is required. Your integration team uses the same tools and patterns they already use for other Salesforce apps.

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On the regulatory side, Smarteeva connects directly to FDA ESG NextGen for MDR submissions and EU EUDAMED for European post-market reporting. On the eQMS side, it runs alongside MasterControl, Veeva Vault QMS, and ETQ, with documented data exchange patterns for teams moving from a general-purpose QMS to a dedicated PMS platform. HL7 FHIR-based EHR integrations are also available for hospital network deployments.

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Smarteeva's standard implementation is a 12-week, four-phase process:

• Phase 1 (Weeks 1-3): Assessment and planning. Smarteeva maps your current complaint workflows, data structures, and integration points.
• Phase 2 (Weeks 4-8): Configuration and data migration. The platform is set up for your products, workflows, and regulatory requirements, and historical data is transferred with full integrity validation.
• Phase 3 (Weeks 9-10): Parallel operation. Smarteeva runs alongside your current system so your team can validate accuracy before cutover.
• Phase 4 (Weeks 11-12): Go-live and legacy decommission. A dedicated support team covers the first 30 days.

Complex multi-site deployments may take longer with a phased rollout. Your regulatory operations continue uninterrupted throughout.

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 Smarteeva's implementation includes role-based training built around how each person uses the platform:

• Quality and regulatory professionals get hands-on training on complaint workflows, investigation management, adverse event detection, and regulatory report generation.
• Salesforce administrators get configuration training on workflow building, decision tree setup, field management, and dashboard creation using standard Salesforce tools.
• Quality leadership gets a focused session on executive dashboards, trend analysis, and quality performance metrics.

Because Smarteeva runs on Salesforce, teams who already know the interface learn it far faster than a proprietary QMS. Most users are productive within the first week. Training documentation, configuration guides, and ongoing reference materials are included.

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 After go-live, Smarteeva provides continuous platform support, regulatory content updates, and every product enhancement as it ships. Standard support covers technical issues, configuration questions, and platform guidance. The first 30 days include dedicated heightened support so your team is fully operational.

Regulatory updates are handled proactively. When the FDA, EU MDR, EUDAMED, or other global frameworks change reporting requirements, Smarteeva updates the relevant templates, submission formats, and validation rules. Your team does not need to track regulatory changes or update the system by hand. For faster response times or a dedicated account manager, enhanced support tiers are available. Contact our team for details.

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 Smarteeva extracts structured complaint data from emails, web forms, bulk files, and medical record PDFs with 96% first-pass extraction accuracy. The intake pipeline adds duplicate detection at 95% accuracy, IMDRF code assignment, and auto-routing to the right investigator queue. Read the complaint intake walkthrough for the full pipeline.

 Smarteeva automates the full post-market workflow:

• Complaint intake
• IMDRF code assignment
• Reportability decisions
• MDR submission to FDA
• PSUR and PMSR generation
• Recall management workflows
• Signal detection across post-market data

Each capability runs inside a connected workflow, with AI agents handling the heavy lifting and human reviewers in the approval loop. See the AI Automation page for the full capability map.

Smarteeva generates a Periodic Safety Update Report in 8 minutes from connected post-market data, against the 6-week industry baseline for manual work. The platform pulls complaint data, drafts narratives aligned to EU MDR Article 86 and FDA periodic reporting, assembles the evidence, and outputs the required regulatory format. The investigator reviews and approves before the report enters the submission package. Read the manual vs automated PSUR breakdown for the comparison.

Smarteeva submits Medical Device Reports to the FDA through the ESG NextGen API in under 3 minutes, from complaint record to FDA acknowledgement. The workflow covers IMDRF coding, Form 3500A field population, and electronic gateway routing. 35% of all FDA MDRs filed each year route through the platform. See the 3-minute MDR walkthrough for details.

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Smarteeva is a Salesforce-native post-market surveillance platform, purpose-built for medical device manufacturers. It connects complaint intake, MDR submission, PSUR generation, recall management, and AI-driven signal detection inside one data model. More than 50,000 users across 80+ countries run their post-market workflows on Smarteeva.

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Smarteeva is built for medical device manufacturers, contract manufacturers, regulatory consultants, and authorized representatives who handle post-market surveillance at scale. It serves quality, regulatory affairs, and complaint handling teams. Customers range from mid-sized device companies to global MedTech enterprises across cardiac, diabetes, orthopedics, surgical robotics, IVD, and digital therapeutics.

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The difference is structural, not just feature-level. Competitors are quality management systems that include post-market surveillance as one module among many, and in some cases PMS is listed under add-ons. Smarteeva was built only for PMS.

Every AI model, workflow template, and regulatory submission format was designed for complaint management, adverse event reporting, PMS reporting, and recall management. Smarteeva also offers two products no competitor has:

• complaints.AI, a public-facing complaint submission tool for end users
• medtechrecalls.com, a recall alert platform for health systems

These extend post-market surveillance beyond the manufacturer's walls, which no QMS vendor does. For teams evaluating alternatives, we offer a complimentary competitive assessment.

Pricing is customized to the modules you select, your user count, your global scale needs, and your data complexity. You pay only for what you need, and you keep the flexibility to expand.

A subscription includes:

• An end-to-end PMS platform with your chosen modules
• Automated regulatory reporting (MDR, MIR, PSUR)
• AI-powered data extraction and signal detection
• API integrations
• Full compliance with audit trails and GxP-ready validation
• Cloud hosting with regular upgrades
• Onboarding and ongoing support

This scales with your operations, reduces overhead, and keeps up with future demands.

Start with a 30-minute introductory call. We ask about your current system, your complaint volume, your regulatory markets, and the specific pain points your team faces. From there, we schedule a tailored demo built on your workflow scenarios, not a generic script.

If the fit is clear, we provide a migration assessment. It covers your implementation timeline (typically 12 weeks), a total cost of ownership comparison against your current system, and a technical architecture review if your IT team needs it. For a hands-on evaluation, Smarteeva offers a structured proof-of-concept engagement. The introductory call and the initial demo carry no cost or obligation.

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