How Smarteeva Maps the Top 5 Post-Market Surveillance Trends for 2024
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Trend 1: Automated Complaint Intake and Initial Assessments
The complaint intake process has historically involved manual data entry, initial assessment, issue coding, and follow-up. In 2024, manufacturers are investing in AI-powered email readers, direct customer complaint submission, and AI-assisted coding and risk assessment.
Smarteeva’s Smart Intake achieves 96% first-pass extraction accuracy. Records that took 15 minutes to create now take under 60 seconds. Automated follow-ups save time and improve accuracy. This is not a future capability. It runs in production across global device companies.
96% first-pass extraction accuracy
<1 min complaint record creation
Trend 2: PMS Report Automation
PSUR, PMSR, PMCF, and MDR generation consume enormous team hours. Precise data aggregation and formatting are required. Manual assembly from fragmented sources is the norm.
Automation has changed this. Smarteeva reduces report generation time by up to 80% by integrating data from ERP systems, complaint-handling systems, and external safety databases. Automated templates, data aggregation, and validation checks cut reporting cycles from months to minutes.
8 min PSUR generation on Smarteeva
80% reduction in report assembly time
Trend 3: Proactive Risk Management
AI now enables real-time risk monitoring as complaints arrive. Instead of quarterly risk reviews based on stale data, manufacturers assess risk continuously. Benchmarking against industry and competitor records adds context that internal data alone cannot provide.
Smarteeva’s Risk Management tool triggers assessments automatically when complaints are created. FMEA/pFMEA/dFMEA scoring updates in real time. MDREngine’s 2.6M+ records provide the industry benchmark.
Trend 4: Industry Data Driving Product and Marketing Decisions
Post-market surveillance data is no longer confined to the quality department. In 2024, marketing and product development teams are using complaint trends, adverse event patterns, and competitive intelligence to inform product roadmaps and positioning.
AI has unlocked this by making large datasets searchable and interpretable. Smarteeva’s MDREngine gives product and marketing teams access to the same safety intelligence that quality teams use, with natural language search and visual dashboards.
Trend 5: AI Agents Replacing RPA
Traditional RPA is rule-based and static. When a complaint deviates from the expected format, the bot breaks. AI agents are different. They use machine learning to adapt dynamically, handling exceptions that would stall an RPA workflow.
Smarteeva Orchestra is the production answer to this trend. Quality teams build AI agents on a drag-and-drop canvas. Each agent can route tasks to different LLMs based on what performs best for that specific step. No code. No IT dependency. Agents go from design to production in 10 minutes.
10 min from blank canvas to running agent
50% more processes automated vs. traditional RPA
Closing
These five trends are operational realities in 2024, not aspirational goals. Smarteeva’s platform addresses each one with production tools, real metrics, and deployments running at global MedTech companies. The question for every manufacturer is not whether these shifts are happening. It is whether your current system can keep up.
