Smarteeva

Founded 2018

Manage medical device complaints and submit adverse event reports to regulatory agencies

Pricing model

Demo

You can use Smarteeva to manage post-market surveillance workflows for medical devices directly inside Salesforce. It lets regulatory and quality teams intake customer complaints, assign IMDRF codes, and evaluate adverse events against international reporting requirements. Teams can assemble and submit Medical Device Reports directly to the FDA through the ESG NextGen API, as well as generate periodic safety update reports. The system also tracks product recalls, aligns risk management files with ISO standards, and maintains detailed audit trails to prepare for inspection deadlines and reviews.

What Smarteeva does

Submit electronic MDRs to the FDAAssign IMDRF codes to incoming device complaintsGenerate periodic safety update reportsEvaluate adverse event reportability by jurisdictionTrack recall notices and customer acknowledgementsExport complaint histories and investigation logs for auditsMonitor complaint trends to identify potential safety hazardsDirect FDA Medical Device Report submission through ESG NextGen APIBidirectional IMDRF code syncing between complaints and regulatory filingsAutomated periodic safety report generation including PSUR and PMSRBuilt-in decision trees to determine MDR and MIR reportabilityAutomated complaint trend monitoring to detect emerging safety signalsNative Salesforce architecture with zero middleware requiredEnd-to-end recall management from notifications to effectiveness checks

Pricing breakdown

Pricing model: Book a demo

Frequently asked

Salesforce

Want a tailored answer?

See whether Smarteeva fits your stack.

Techbible weighs Smarteeva against what you already pay for, your team shape, and the work that's actually happening. Free to start.

Side by side

Compare Smarteeva

Search the catalog or pick a similar tool to compare pricing, features, and fit.

Or pick from similar tools

More in Healthcare & Life Sciences

All tools →

Luminai

Automate repetitive healthcare administrative tasks across disconnected hospital systems and records

Rhazes AI

Transcribe patient consultations, generate clinical notes, and suggest billing codes in real time

Tennr

Automate patient intake, insurance verification, and care coordination workflows for healthcare providers

10x Science

Characterize proteins and analyze complex peptide mapping data in real time

3QHS

Manage value-based care programs, risk stratification, and patient interventions for healthcare organizations

Abacus Insights

Unify fragmented healthcare payer data into organized records for compliance and cost management

Abett

Collect and manage healthcare data for self-insured employers

Abridge

Transcribe patient visits and draft clinical notes automatically during medical appointments