Frequently asked questions
Smarteeva takes a fundamentally different approach. We built one unified platform where every product shares the same data model, the same AI engine, the same audit trail, and the same Salesforce.
General
Our pricing is customized based on the selected modules, user count, global scalability needs, and data complexity, ensuring you only pay for what you need while retaining flexibility to expand. A Smarteeva subscription includes an end-to-end PMS platform with your chosen modules, automated regulatory reporting (MDR, MIR, PSUR), AI-powered automation for intelligent data extraction and signal detection, seamless API integrations, full compliance with audit trails and GxP-ready validation, cloud hosting with regular upgrades, and comprehensive onboarding and ongoing support. This approach guarantees a solution that scales with your operations, reduces overhead, and evolves to meet future demands.
Start with a 30-minute introductory call. We will 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 product demo that uses your workflow scenarios, not a generic script. If the fit is clear, we provide a migration assessment covering 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 organizations that want a hands-on evaluation, Smarteeva offers a structured proof-of-concept engagement. There is no cost or obligation for the introductory call or the initial demo.
The difference is structural, not just feature-level. Competitors are quality management systems that include post-market surveillance as one module among many. In some cases, PMS is listed under 'add-ons.' Smarteeva was built exclusively for PMS. Every AI model, every workflow template, every regulatory submission format in the platform 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) and medtechrecalls.com (a recall alert platform for health systems). These extend post-market surveillance beyond the manufacturer's walls, which is something no QMS vendor does. For organizations evaluating alternatives, we offer a complimentary competitive assessment.
Product
Smarteeva runs 100% natively on Salesforce and AWS. All data is stored within Salesforce's enterprise cloud infrastructure, which maintains SOC 2 Type II compliance, ISO 27001 certification, HIPAA eligibility, and encryption at rest and in transit. The platform inherits Salesforce's complete security model: role-based access controls, field-level security, audit trails with full traceability, electronic signatures (21 CFR Part 11 compliant), and multi-factor authentication. Smarteeva does not use any proprietary database or third-party storage outside the Salesforce and AWS ecosystem. For organizations with data residency requirements, Salesforce provides regional data center options. Your information security team evaluates one platform, not two.
s
Smarteeva integrates with your existing enterprise systems without requiring you to replace them. Because the platform is built natively on Salesforce, it uses standard Salesforce APIs (REST, SOAP, Bulk, and Streaming) for integration. Smarteeva customers have connected the platform to ERP systems for product master data and lot tracking, LIMS for laboratory investigation results, field service platforms for on-site complaint capture, customer service tools including Salesforce Service Cloud (natively, with zero middleware), and 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 applications.
After go-live, Smarteeva provides continuous platform support, regulatory content updates, and access to every product enhancement as it ships. Standard support covers technical issues, configuration questions, and platform guidance. The first 30 days after go-live include dedicated heightened support to ensure 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 in the platform. Your team does not need to track regulatory changes and manually update the system. For organizations that need faster response times or a dedicated account manager, enhanced support tiers are available. Contact our team for details on support options.
Support
Smarteeva's standard implementation follows a 12-week, four-phase process. Phase 1 (Weeks 1-3): Assessment and planning, where Smarteeva maps your current complaint workflows, data structures, and integration points. Phase 2 (Weeks 4-8): Configuration and data migration, where the platform is set up for your specific products, workflows, and regulatory requirements, and historical data is transferred with full integrity validation. Phase 3 (Weeks 9-10): Parallel operation, where Smarteeva runs alongside your current system so your team can validate accuracy before cutover. Phase 4 (Weeks 11-12): Go-live and legacy decommission, with a dedicated support team for the first 30 days. Complex multi-site deployments may take longer with a phased rollout. Your regulatory operations continue uninterrupted throughout the process.
Smarteeva's implementation includes role-based training designed for how each person actually uses the platform. Quality and regulatory professionals receive hands-on training focused on complaint workflows, investigation management, adverse event detection, and regulatory report generation. Salesforce administrators receive configuration training covering workflow building, decision tree setup, field management, and dashboard creation using standard Salesforce tools. Quality leadership receives a focused session on executive dashboards, trend analysis, and quality performance metrics. Because Smarteeva runs on Salesforce, teams already familiar with the Salesforce interface find the learning curve significantly shorter than with proprietary QMS platforms. Most users are productive within the first week. Training documentation, configuration guides, and ongoing reference materials are included.
After go-live, Smarteeva provides continuous platform support, regulatory content updates, and access to every product enhancement as it ships. Standard support covers technical issues, configuration questions, and platform guidance. The first 30 days after go-live include dedicated heightened support to ensure 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 in the platform. Your team does not need to track regulatory changes and manually update the system. For organizations that need faster response times or a dedicated account manager, enhanced support tiers are available. Contact our team for details on support options.
