Partner Readiness Checklist of your product

1. Regulatory Clearance

1. Regulatory Clearance

1. Regulatory Clearance

FDA clearance (510(k), De Novo, or PMA) for devices
FDA SaMD approval for qualifying software
CLIA compliance for lab/pathology tools

2. Clinical Validation

1. Regulatory Clearance

1. Regulatory Clearance

Published clinical data showing safety, efficacy, and measurable outcomes
Case studies or pilot program results from credible providers
Optional: reference sites or testimonials

3. Market-Ready Assets

1. Regulatory Clearance

4. Operational Readiness

Finalized, ready-to-ship product with stable design
Sales training materials (slide decks, brochures, demo videos)
Clear pricing structure and commercial terms

4. Operational Readiness

5. Hospital Buyer Enablement

4. Operational Readiness

Inventory in stock or rapid fulfillment (≤ 4 weeks)
Customer support and technical onboarding resources
Defined warranty and service terms

5. Hospital Buyer Enablement

5. Hospital Buyer Enablement

5. Hospital Buyer Enablement

Tailored value proposition for U.S. health systems
ROI calculators, workflow integration examples, or cost-benefit analysis
Prepared answers to common procurement and compliance questions