FDA QMSR Validated Platform

The medical device QMSbuilt for startups,priced for reality.

Deploy an FDA QMSR, ISO 13485, and EU MDR-ready Quality Management System in weeks, not 12 months. Pre-configured DHF, Design Controls, ISO 14971 risk registers, and 510(k) submission workflows, with AI-powered configurability.

FDA QMSR Validated
ISO 13485 Aligned
21 CFR Part 11
EU MDR Ready
Illustration of a connected medical device design and pre-market quality system
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 Deploy
$380/mo
Up to 5 Users
60+
Business Applications
1st
ISO 42001 AI Module

Built for the Next Generation of MedTech Companies

Gentherm Medical
Kosma Kare
Sonic Incytes Medical Corp.
Neuro Spinal Innovation Inc.
InkSpace Imaging
Conavi Medical
Mukava Biosignals
Why Cloudtheapp

The numbers competitors don't print on their pages.

Most QMS vendors won't publish pricing, deployment time, or contract terms. We do, because they're our advantage.

Disconnected systems put your 510(k) at risk

Spreadsheets and silos leave your DHF fragmented. FDA reviewers see the gaps. Submissions get placed on hold.

One connected system where every document, risk file, and design record is linked with closed-loop traceability.

Months of setup before you're audit-ready

Legacy QMS platforms take 6 to 12 months to configure. Your regulatory timeline can't wait, and every month of delay is a month of market loss.

Pre-configured 510(k) Ready Kit with FDA QMSR workflows, DHF templates, and audit-tested SOPs on day one.

Locked into contracts before your first audit

Rigid, multi-year contracts trap startups before they've cleared their first FDA inspection or proven market fit.

Starting at $380/mo for up to 5 users. No mandatory lock-in. Pricing that respects your startup runway.

Manual approvals don't survive a Part 11 audit

Email approvals and printed sign-off sheets fail 21 CFR Part 11 audit trail requirements. Inspectors notice immediately.

Built-in e-signatures, role-based reviews, and an immutable audit trail, Part 11 compliant from day one.

No internal QA/RA team, and no budget for one

A full QA/RA team costs $500K+. Most startups can't justify the headcount before their first submission.

Configurable applications, workflows, and automation help a 2-person team operate like a much larger quality organization.

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.

Describe a workflow in plain English. Cloudtheapp builds it, then governs it under ISO 42001.
Applications

Preconfigured applications for medical device compliance.

Each application ships with FDA- and ISO-aligned workflows, records, and templates, so your team starts with a regulated foundation, not a blank page.

Controlled Document Management

Documents

Learn More

Operate a document control system for SOPs, work instructions, design records, and quality manuals, with version history, electronic approval workflows, and 21 CFR Part 11-compliant e-signatures.

Capabilities
  • Hierarchical SOP and work-instruction templates preloaded for ISO 13485
  • Effective dates, periodic review cycles, and obsolescence tracking
  • Role-based reviewer routing with electronic signatures
  • Immutable audit trail with revision-level diff
Compliance Coverage
ISO 13485 Β§4.2.421 CFR 820.4021 CFR Part 11
Why it matters

Audit-ready document of record for FDA inspections and ISO certification bodies.

Explore all Applications

Explore the complete Applications Hub to discover 60+ prebuilt applications for Quality, Safety, Compliance, Manufacturing, Clinical, Laboratory, and Business Operations.

Closed-Loop Traceability

From user need to validation evidence, fully traced.

Every design record in Cloudtheapp is connected. Reviewers and auditors get complete visibility in seconds, not hours.

User Need
Design Input
Design Output
Verification
Validation
Risk Control
Design Transfer

When a design input changes, it automatically links to the affected design output, its verification test, and the associated risk control in your ISO 14971 file, giving you and your FDA reviewer complete, navigable design traceability in seconds. This is the traceability that clears submissions.

Regulatory Coverage

Built for every regulation your device must meet.

The most complete regulatory coverage of any medical device QMS platform, including the FDA QMSR February 2026 harmonized update.

FDA 21 CFR 820 / QMSR

Full QMSR compliance including the Feb 2026 harmonized update.

ISO 13485:2016

Complete QMS for medical devices. Certification-ready from day one.

ISO 14971:2019

Full product lifecycle risk file, hazard analysis through residual risk.

EU MDR 2017/745

Article 10 obligations, technical documentation, GSPR Annex I, and conformity assessment.

21 CFR Part 11

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

IEC 62304

Software lifecycle for devices and SaMD (Software as a Medical Device).

MDSAP

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

ISO 42001 AI Management

Cloudtheapp exclusive. The first QMS with a purpose-built AI management module.

Quality Foundation

Build the Quality Foundation for Your Regulatory Submission

Cloudtheapp provides the configurable quality management platform organizations use to establish compliant processes, maintain complete traceability, and generate the records and documentation that support FDA, EU MDR, ISO 13485, and other regulatory submissions.

Platform & Security

Configure users, roles, electronic signatures, audit trails, and security controls to support regulated quality processes.

Quality System

Configure your quality processes including Document Control, Training, Design Controls, Risk Management, Change Management, and CAPA.

Traceability & Records

Capture and maintain complete quality records, approvals, and end-to-end traceability throughout the product lifecycle.

Submission Support

Generate and maintain the quality records, documentation, and traceability required to support FDA 510(k), De Novo, EU MDR, ISO 13485, and other regulatory submissions.

Starter Package
Cloudtheapp Medical Device QMS

Everything you need to build your digital Quality Management System for your first 510(k).

A pre-configured Cloudtheapp environment with medical device quality applications and workflows that help your team manage documents, design controls, risk management, training, CAPA, and the records that support regulatory submissions.

  • Pre-configured Applications Document Control, Design Controls, Risk Management, CAPA, Change Management, Training, Supplier Quality, Complaints, and more.
  • Configurable Quality Workflows Adapt applications, forms, fields, workflows, approvals, and reports to match your organization's quality processes.
  • Complete Traceability Maintain end-to-end traceability across quality records, documents, approvals, design history, and risk management activities.
  • Guided Implementation Work with Cloudtheapp specialists to configure your environment and onboard your team.
  • Built for Regulated Industries Electronic signatures, audit trails, role-based security, and 21 CFR Part 11 capabilities.
  • Scales Beyond Your First Submission Expand with 60+ integrated applications as your organization grows.
510(k) Ready Kit Pricing
Cloudtheapp Medical Device QMS
For medical device startups and growing manufacturers
$380/month
Up to 5 users
  • Month-to-month subscription
  • No long-term contracts
  • Guided implementation available
  • Expand to 60+ integrated applications
  • Upgrade anytime as your organization grows
  • Additional users available as needed
Start Your Medical Device QMS→

No credit card for demo Β· Implementation in weeks, not months

How We Compare

What most medical device QMS platforms get wrong.

Feature✦ CloudtheappLegacy MedTech QMS
AI-powered no-code workflow configurabilityβœ“βœ—
Month-to-month startup pricingβœ“βœ—
Transparent pricing published on websiteβœ“βœ—
Pre-configured 510(k) workflows on day oneβœ“βœ—
Implement in weeks not 6 to 12 monthsβœ“βœ—
ISO 42001 AI Management System moduleβœ“βœ—
60+ apps across regulated industriesβœ“βœ—
FDA QMSR, 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. Design controls, risk, verification and validation, and documents link into one traceable DHF that is ready to support a 510(k) submission.

No. It fits emerging device companies and scales into more mature programs without a rebuild.

It makes traceability easy to show across design, risk, validation, change control, 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 plus the teams closest to design and development, with shared visibility across regulatory and leadership.

Yes. Routing, fields, approvals, and dashboards are configurable, so the system evolves without starting over.

Get Started

Build your medical device QMS before your first submission.

Move faster than your competition with a startup-ready compliance platform purpose-built for FDA and ISO 13485 preparation.

βœ… FDA QMSR Validatedβœ… ISO 13485 Aligned⚑ Deploy in WeeksπŸ”’ No Multi-Year Lock-in