Services and Solutions
THE PROBLEM: The Post-Clearance Trap
You’ve invested years and significant capital to achieve regulatory clearance. But to sell and scale a medical device, you face a second, often underestimated barrier: building and maintaining a compliant operating organization.
Who We Serve
- Post-510(k) startups
- Established manufacturers expanding product portfolios
- Strategic and innovation teams
- Compliance and quality organizations modernizing systems
The Talent Gap
Senior quality and operations leaders are expensive, slow to hire, and difficult to retain.
The Time Gap
ISO 13485 and FDA QMSR-aligned systems typically take months to implement properly.
The Operations Gap
Supplier qualification, complaint handling, CAPA, and post-market vigilance must be in place before meaningful revenue can scale.
The Reality
Most companies burn a significant portion of their runway building internal infrastructure before generating sustainable revenue.
The Clearway Difference
We activate a full commercialization and quality platform in weeks allowing companies to operate professionally, compliantly, and efficiently without building internal organizations.
THE SOLUTION: Your Dedicated Operations Partner
Clearway Medical operates as a long-term operational partner, not a transactional service provider. Our clients retain legal manufacturer status and regulatory authority. We execute the regulated operating layer through formal quality and supplier agreements that define responsibilities, audit rights, and escalation pathways.
Our Core Services
Quality Systems & Regulatory Execution
The Deliverable: A fully aligned ISO 13485 and FDA QMSR (21 CFR 820) quality management system, implemented and maintained under a documented quality agreement.
The Execution: We operate document control, CAPA, internal audits, supplier audits, design transfer support, and inspection readiness as your dedicated execution partner.
The Value: You remain continuously audit-ready without hiring or managing an internal quality organization
Supplier & Manufacturing Network Management
The Deliverable: A qualified, scalable supplier and manufacturing ecosystem aligned with your regulatory and commercial requirements.
The Execution: We qualify suppliers, manage contract manufacturers, execute purchasing, and control incoming and final product acceptance.
The Value: You scale production up or down without adding operational headcount or introducing compliance risk.
Post-Market Surveillance & Vigilance
The Deliverable: A structured, compliant post-market surveillance and complaint handling program.
The Execution: We intake complaints, conduct investigations, prepare MDR packages, trend performance data, and maintain recall readiness.
The Value: You protect patients, brand reputation, and regulatory standing without building internal compliance teams.
Acquisition & Enterprise Readiness
The Deliverable: A clean, well-governed operational and quality documentation environment.
The Execution: We prepare diligence materials, supplier portfolios, and regulatory readiness assessments.
The Value: You enable partnerships, growth, and strategic transactions with minimal friction and operational risk.
AI-Enabled & Software-Based Medical Devices
The Deliverable: A compliant regulatory and quality operating framework for AI/ML and software-based medical devices, aligned with FDA guidance, ISO 13485, and Good Machine Learning Practice (GMLP).
The Execution: We support model lifecycle governance, data and algorithm change control, predetermined change control plans (PCCPs), design controls, risk management, supplier and data pipeline oversight, and post-market performance monitoring.
The Value: You innovate in AI and digital health without building an internal regulatory, quality, and compliance organization while remaining inspection-ready as FDA expectations evolve.