Partnership & Governance
Regulatory Boundaries
Clearway Medical operates as a commercialization and quality operations partner. Our clients retain legal manufacturer status and regulatory authority. Clearway Medical does not act as the regulatory reporting entity, distributor, or legal manufacturer.
Governance Framework
- Regulatory authority retention
- Execution responsibilities
- Audit rights and inspection protocols
- Change control and escalation pathways
Confidentiality & Data Ownership
All technical documentation, regulatory records, and quality data remain the property of the client. Clearway Medical operates under strict confidentiality, data protection, and audit transparency principles.
Responsibility Matrix (RACI)
| Function | Client | Clearway |
|---|---|---|
| FDA Registration | ✓ | — |
| MDR Submission | ✓ | Support |
| Supplier Qualification | — | ✓ |
| Complaint Investigation | Support | ✓ |
| CAPA Management | Approval | Continuous |
| CAPA Management | ✓ | Execution |
How We Govern & Share Responsibility
You Retain
- Legal manufacturer of record status
- Regulatory authority and FDA registration
- Final MDR and regulatory submissions
- Commercial strategy and sales execution
Clearway Executes
- Quality system implementation and operation
- Supplier qualification and oversight
- Manufacturing coordination and release processes
- Complaint intake, investigation, and trending
- CAPA, change control, and audit readiness
| Feature | Traditional Internal Model | Clearway Partnership |
|---|---|---|
| Time To Operational Readiness | 9–18 Months | 4–8 Weeks |
| Annual Fixed Cost | High (Quality, Ops, Compliance Staff) | Variable, Engagement-Based |
| Scalability | Headcount-Dependent | Volume-Dependent |
| Regulatory Risk | Individual-Dependent | System-Based, Team-Executed |
| Audit Readiness | Periodic | Continuous |
Engagement Models
Flexible Structures for Different Stages and Operating Needs
Clearway Medical offers multiple partnership models designed to align with your company’s maturity, complexity, and growth objectives.
Monthly Operating Partnership
Best for: Active commercialization and ongoing operations
A flat monthly engagement covering full quality, supplier, and post-market execution.
Cost-Plus Operations
Best for: Complex supply chains and multi-supplier environments
We manage operational and supplier spend with a transparent management margin.
Hybrid Equity Model
Best for: Early-stage and pre-revenue companies
Reduced operating fees combined with equity participation to preserve runway.