For Cleared & CE-Marked Devices Β· FDA QMSR Feb 2026 Ready

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.

FDA MDR Β· 21 CFR 803
EU MDR Vigilance
ISO 13485 Β§8
21 CFR Part 11
Quality specialist in cleanroom gowning recording device history data on a tablet beside a sterile packaging line of single-use medical devices under ISO 13485 controls
Lifecycle coverage

Design, DMR, complaints, and vigilance can live on one platform.

Audit-ready traceability

Design, risk, validation, and field signals are easier to connect and defend.

Faster deployment

Medical-device workflows do not need to be invented from scratch.

Weeks
To Go Live
100%
Configurable
60+
Applications
1st
ISO 42001 AI Module

Built for the Next Generation of MedTech Companies

Gentherm Medical
Kosma Kare
Sonic Incytes
Neuro Spinal
InkSpace Imaging
Conavi Medical
Mukava Biosignals
Why Cloudtheapp

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.

Dashboards and analytics provide visibility into reporting timelines, due dates, and historical performance, helping reduce missed deadlines and improve regulatory oversight.

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.

One closed loop links every complaint to its investigation, reportability decision, CAPA, and risk update.

PMS and PMCF evidence is scattered

Field feedback arrives as emails, PDFs, and spreadsheets, impossible to trend or defend during a PSUR or audit.

AI-built surveys and QR-code intake feed structured PMS/PMCF data straight into trending and your PSUR.

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.

Surveillance findings update the live risk file automatically, keeping residual-risk conclusions current.

Every audit becomes a fire drill

Reconstructing complaint trends, CAPA status, and management-review records before a notified-body audit burns weeks.

A continuously audit-ready QMS with audit schedules, checklists, and a complete history of record.

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.

Build surveillance workflows in plain English, then govern your AI under ISO 42001.
Applications

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.

PMS & PMCF Data Collection

Post-Market Surveys

Learn More

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.

Capabilities
  • 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
Compliance Coverage
EU MDR Art. 83-86EU MDR Annex XIV (PMCF)ISO 13485 Β§8.2
Why it matters

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.

The Surveillance Loop

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.

Field Signal
Complaint
Reportability
CAPA
Risk Update
Management Review

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.

Regulatory Coverage

Built for every post-market obligation.

Complete vigilance and surveillance coverage across FDA and EU, including the FDA QMSR February 2026 harmonized update.

FDA 21 CFR 803 (MDR)

Medical Device Reporting with automated 5, 10, and 30-day clocks.

FDA 21 CFR 820 / QMSR

Full QMSR compliance including the Feb 2026 harmonized update.

EU MDR Art. 83-92

PMS, PMCF, vigilance, and trend reporting obligations.

ISO 13485 Β§8

Measurement, analysis, and improvement, complaints through CAPA.

ISO 14971:2019

Live risk management file updated by post-market data.

21 CFR Part 11

E-records and e-signatures, full audit trail and controlled access.

MDSAP

Single audit framework covering US, Canada, Brazil, Japan, Australia.

ISO 42001 AI Management

The first QMS with a purpose-built AI management module, designed for regulated organizations.

Guided Implementation

Live Post-Market Surveillance

A guided implementation that helps your team configure post-market surveillance processes, quality workflows, and regulatory reporting in Cloudtheapp.

Phase 1

Platform Setup

Configure your workspace, users, roles, electronic signatures, audit trails, and security.

Phase 2

Complaints & Regulatory Reporting

Configure complaint handling, FDA MDR and EU MDR reporting processes, and reporting deadline tracking.

Phase 3

CAPA, PMS & Risk Management

Configure CAPA, Post-Market Surveillance (PMS), Risk Management, surveys, and traceability.

Go Live

Operational Readiness

Your quality system is configured and ready to support post-market surveillance activities, management reviews, and regulatory reporting.

Commercial Package
Post-Market Surveillance

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.
Post-Market Surveillance Pricing
Commercial, Post-Clearance
For cleared and CE-marked medical devices
$740/month
Up to 10 users
  • 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
Start Post-Market Surveillance→
How We Compare

What most QMS platforms get wrong about post-market.

Feature✦ CloudtheappLegacy MedTech QMS
Automated FDA & EU MDR reporting clocksβœ“βœ—
Closed loop: complaint β†’ CAPA β†’ risk fileβœ“βœ—
AI-built PMS / PMCF surveys with QR intakeβœ“βœ—
PSUR & trend reporting from live dataβœ“βœ—
Post-market data feeds the ISO 14971 risk fileβœ“βœ—
Month-to-month pricing, no lock-inβœ“βœ—
ISO 42001 AI Management System moduleβœ“βœ—
FDA QMSR Feb 2026 update, ready todayβœ“βœ—
Customer Stories

Trusted by quality teams across life sciences.

Fast-Track Implementation

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.

Frequently asked questions

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.

Get Started

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.

βœ… FDA MDR Trackingβœ… EU MDR Vigilance⚑ Live in WeeksπŸ”’ No Multi-Year Lock-in