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.

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
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.
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.
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.
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.
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.
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 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.
Documents
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.
- 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
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.
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.
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.
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.
Full QMSR compliance including the Feb 2026 harmonized update.
Complete QMS for medical devices. Certification-ready from day one.
Full product lifecycle risk file, hazard analysis through residual risk.
Article 10 obligations, technical documentation, GSPR Annex I, and conformity assessment.
E-records and e-signatures, full audit trail and controlled access.
Software lifecycle for devices and SaMD (Software as a Medical Device).
Single audit framework covering US, Canada, Brazil, Japan, Australia.
Cloudtheapp exclusive. The first QMS with a purpose-built AI management module.
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.
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.
- 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
No credit card for demo Β· Implementation in weeks, not months
What most medical device QMS platforms get wrong.
| Feature | β¦ Cloudtheapp | Legacy MedTech QMS |
|---|---|---|
| AI-powered no-code workflow configurability | β | β |
| Month-to-month startup pricing | β | β |
| Transparent pricing published on website | β | β |
| Pre-configured 510(k) workflows on day one | β | β |
| Implement in weeks not 6 to 12 months | β | β |
| ISO 42001 AI Management System module | β | β |
| 60+ apps across regulated industries | β | β |
| FDA QMSR, 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. 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.
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.