Post-market surveillancethat keeps you compliant,and audits effortless.
Track FDA MDR and EU MDR vigilance clocks, run closed-loop complaints and CAPA, and generate PMS/PMCF and PSUR evidence, all traced back to your design records. Deploy in weeks, governed by a purpose-built ISO 42001 AI module.

Design, DMR, complaints, and vigilance can live on one platform.
Design, risk, validation, and field signals are easier to connect and defend.
Medical-device workflows do not need to be invented from scratch.
Built for the Next Generation of MedTech Companies
Surveillance that runs itself, not your team.
Most QMS vendors bolt post-market onto a design tool. We built a connected surveillance loop, with clocks, trending, and traceability included.
MDR clocks slip through the cracks
Manual tracking of 5, 10, and 30-day FDA and EU reporting deadlines makes a missed clock easy to overlook.
Complaints and CAPA live in separate tools
When complaints, adverse events, and CAPA don't connect, root cause is slow and trends stay invisible until it's too late.
PMS and PMCF evidence is scattered
Field feedback arrives as emails, PDFs, and spreadsheets, impossible to trend or defend during a PSUR or audit.
Post-market signals never reach the risk file
If real-world data doesn't flow back to ISO 14971, your benefit-risk conclusions go stale and EU MDR Article 83 isn't met.
Every audit becomes a fire drill
Reconstructing complaint trends, CAPA status, and management-review records before a notified-body audit burns weeks.
AI features are bolted on, not built in
Competitors talk about AI. Cloudtheapp includes an AI Application Builder and an ISO 42001 AI Management module designed for regulated organizations.
Preconfigured applications for post-market surveillance.
Each application ships with FDA- and ISO-aligned vigilance workflows, records, and reporting, so surveillance runs as one connected loop.
Post-Market Surveys
Collect real-world device performance data from clinicians and patients with AI-built, mobile-friendly surveys and QR-code intake, feeding your PMS plan, PMCF, and trending with structured, analyzable evidence.
- AI-assisted survey builder (Thunder) with QR-code public submission
- PMS plan and PMCF data collection aligned to EU MDR Annex XIV
- Real-time analytics and trend dashboards by device, lot, and region
- Findings routed to complaints, CAPA, and risk updates
Turn field experience into structured surveillance evidence, not scattered emails and PDFs.
Explore all Applications
Explore the complete Applications Hub to discover 60+ prebuilt applications for Quality, Safety, Compliance, Manufacturing, Clinical, Laboratory, and Business Operations.
From field signal to risk update, fully closed.
Every post-market signal flows through one connected loop, so nothing is dropped and everything is traceable.
A complaint from the field is screened for reportability, files its MDR or vigilance report on the clock, drives a CAPA, updates the ISO 14971 risk file, and surfaces in management review, every step linked and timestamped for your notified body. This is the loop that keeps a cleared device compliant.
Built for every post-market obligation.
Complete vigilance and surveillance coverage across FDA and EU, including the FDA QMSR February 2026 harmonized update.
Medical Device Reporting with automated 5, 10, and 30-day clocks.
Full QMSR compliance including the Feb 2026 harmonized update.
PMS, PMCF, vigilance, and trend reporting obligations.
Measurement, analysis, and improvement, complaints through CAPA.
Live risk management file updated by post-market data.
E-records and e-signatures, full audit trail and controlled access.
Single audit framework covering US, Canada, Brazil, Japan, Australia.
The first QMS with a purpose-built AI management module, designed for regulated organizations.
Live Post-Market Surveillance
A guided implementation that helps your team configure post-market surveillance processes, quality workflows, and regulatory reporting in Cloudtheapp.
Platform Setup
Configure your workspace, users, roles, electronic signatures, audit trails, and security.
Complaints & Regulatory Reporting
Configure complaint handling, FDA MDR and EU MDR reporting processes, and reporting deadline tracking.
CAPA, PMS & Risk Management
Configure CAPA, Post-Market Surveillance (PMS), Risk Management, surveys, and traceability.
Operational Readiness
Your quality system is configured and ready to support post-market surveillance activities, management reviews, and regulatory reporting.
Everything you need to manage post-market surveillance in one configurable platform.
A pre-configured Cloudtheapp environment with integrated applications and workflows for managing complaints, CAPA, post-market surveillance, adverse events, customer returns, audits, and risk management for cleared and CE-marked medical devices.
- Pre-configured Applications Complaints, Adverse Events, CAPA, Nonconforming Material, Customer Returns, Audits, Management Review, Risk Management, and more.
- Configurable Regulatory Workflows Configure FDA MDR and EU MDR reporting processes, data capture, dashboards, and reporting deadline tracking.
- PMS, PMCF & PSUR Management Manage post-market surveillance activities and maintain the records and evidence that support PMS, PMCF, and PSUR documentation.
- Trending & Analytics Analyze complaints, returns, adverse events, and quality trends through configurable dashboards and analytics.
- Management Review & Audit Support Maintain management review records, audit schedules, findings, and related quality activities in one platform.
- Integrated Risk Management Link post-market quality events, CAPA, complaints, and risk records with complete traceability.
- Month-to-month, no long-term contracts
- Scales as your organization grows
- Expand with 60+ integrated applications
- ISO 42001 AI module available as an add-on
- Enterprise-grade AWS cloud platform
- Bundle with the Pre-Market package for a complete quality lifecycle
What most QMS platforms get wrong about post-market.
| Feature | β¦ Cloudtheapp | Legacy MedTech QMS |
|---|---|---|
| Automated FDA & EU MDR reporting clocks | β | β |
| Closed loop: complaint β CAPA β risk file | β | β |
| AI-built PMS / PMCF surveys with QR intake | β | β |
| PSUR & trend reporting from live data | β | β |
| Post-market data feeds the ISO 14971 risk file | β | β |
| Month-to-month pricing, no lock-in | β | β |
| ISO 42001 AI Management System module | β | β |
| FDA QMSR Feb 2026 update, ready today | β | β |
Your solution. Configured and live in as little as 30 days.
Start with the applications your team needs most, configured for your processes and ready for production in a few weeks.
Start with a clear scope
Select the initial applications, workflows, and priorities your team needs first.
Configured for your processes
We configure the selected applications around the way your organization works.
Guided through go-live
Clear milestones, team reviews, training, and a structured path to production.
Questions buyers are likely to ask
Yes. Complaints, adverse events, CAPA, audits, and post-market surveillance stay connected in one closed loop.
It makes post-market traceability easy to show across complaints, CAPA, risk updates, and management review.
A focused first release can start with the highest-priority workflows, then expand into adjacent applications without rebuilding the operating model.
Ownership usually spans quality and regulatory plus the teams closest to complaints and field feedback, with leadership visibility.
Yes. Routing, fields, approvals, and dashboards are configurable, so the system evolves without starting over.
Keep your cleared device compliant, effortlessly.
Run FDA and EU MDR post-market surveillance as one connected loop, with vigilance clocks, trending, and audit readiness built in.