Shorelight Medical
US-based commercialization partner providing end-to-end services to bring medical devices and pharmaceuticals to the U.S. market. Offers product development from concept through manufacturing, regulatory and quality support (including FDA pathways and 510(k) submissions), manufacturing coordination with U.S. and international contract manufacturers, market entry and sales/distribution services, and business and IP advisory services.
Industries
N/A
Services
US-based medical manufacturing
Manufacturing services aligned with ISO 13485:2016 for medical devices and pharmaceuticals, with quality assurance processes to meet specifications.
Medical product development
End-to-end product development including concept validation, prototyping, engineering, packaging, and preparation for manufacturing to minimize rework.
Regulatory compliance and quality management
Regulatory and quality services including preparation for regulatory filings, 510(k) submissions, audits, and clinical/lab testing coordination.
Medical industry sales and distribution
Sales and distribution services for the U.S. healthcare market, leveraging distributor networks, OEM and licensing channels, and relationships with hospital systems.
Healthcare business consulting
Business planning, strategic planning, market analysis, risk assessment, and valuation services for healthcare products.
Go-to-market partnership and commercialization
Integrated commercialization services combining product development, regulatory, manufacturing, and sales to streamline market entry and reduce coordination overhead.
US-based medical manufacturing
Manufacturing services aligned with ISO 13485:2016 for medical devices and pharmaceuticals, with quality assurance processes to meet specifications.
Medical product development
End-to-end product development including concept validation, prototyping, engineering, packaging, and preparation for manufacturing to minimize rework.
Regulatory compliance and quality management
Regulatory and quality services including preparation for regulatory filings, 510(k) submissions, audits, and clinical/lab testing coordination.
Medical industry sales and distribution
Sales and distribution services for the U.S. healthcare market, leveraging distributor networks, OEM and licensing channels, and relationships with hospital systems.
Healthcare business consulting
Business planning, strategic planning, market analysis, risk assessment, and valuation services for healthcare products.
Go-to-market partnership and commercialization
Integrated commercialization services combining product development, regulatory, manufacturing, and sales to streamline market entry and reduce coordination overhead.
Expertise Areas
- Medical device manufacturing
- Pharmaceutical manufacturing
- Product development and prototyping
- Regulatory compliance and FDA submissions
Key Technologies
- ISO 13485 quality management systems
- Design for manufacturability (DFM)
- Prototype development
- Lean manufacturing