Prospect Life Sciences
Prospect Life Sciences is a medical device development and manufacturing partner offering integrated, end-to-end solutions from concept through global market fulfillment. The company provides comprehensive capabilities in research and design, product development, manufacturing transfer, scalable production, and regulatory compliance, leveraging ISO 13485:2016-certified and FDA-registered quality management systems. With facilities in the USA and Costa Rica, the company serves as a strategic partner for both early-stage and established organizations, enabling efficient, compliant, and scalable innovation in the medical device sector.
Industries
N/A
Prospect Life Sciences
11025 Dover Street, Westminster, Colorado
Patents
Services
Integrated services covering research and design, product engineering, regulatory compliance, manufacturing transfer, and scalable production for medical devices from concept to commercialization.
Guidance and hands-on services for regulatory submissions (FDA, CE, ISO 13485), preparation of design history files, risk management, and gap remediation in quality management systems.
Comprehensive validation of manufacturing processes, equipment, and supply chains, ensuring compliant and efficient transition to scalable, high-quality production.
ISO 13485/FDA QSR-compliant device manufacturing including assembly, inspection, packaging, batch production, and global fulfillment. Services span both US-based and nearshore (Costa Rica) facilities for cost and logistical optimization.
Integrated services covering research and design, product engineering, regulatory compliance, manufacturing transfer, and scalable production for medical devices from concept to commercialization.
Guidance and hands-on services for regulatory submissions (FDA, CE, ISO 13485), preparation of design history files, risk management, and gap remediation in quality management systems.
Comprehensive validation of manufacturing processes, equipment, and supply chains, ensuring compliant and efficient transition to scalable, high-quality production.
ISO 13485/FDA QSR-compliant device manufacturing including assembly, inspection, packaging, batch production, and global fulfillment. Services span both US-based and nearshore (Costa Rica) facilities for cost and logistical optimization.
Expertise Areas
- Medical device development
- Design history file and technical documentation
- New product introduction (NPI)
- Process validation (IQ, OQ, PQ)
Key Technologies
- CAD modeling
- Software modeling
- Process validation (IQ, OQ, PQ)
- Lean manufacturing practices
Key People
CEO/President
Head of Quality and Manufacturing Engineering
Head of Regulatory and Research
Head of Product Development
Head of Operations
CEO/President
Head of Quality and Manufacturing Engineering
Head of Regulatory and Research
Head of Product Development
Head of Operations
News & Updates
Announced new partnership in Costa Rica to expand capacity for high-volume medical device production and strategic supply chain control.
Spinal Stabilization Technologies began a clinical trial for a nucleus replacement device, with development and support involving Prospect Life Sciences.
Participated in the Med Device Forum in Costa Rica, joining industry professionals to discuss trends and challenges in medical device development and manufacturing.
Announced new partnership in Costa Rica to expand capacity for high-volume medical device production and strategic supply chain control.
Spinal Stabilization Technologies began a clinical trial for a nucleus replacement device, with development and support involving Prospect Life Sciences.
Participated in the Med Device Forum in Costa Rica, joining industry professionals to discuss trends and challenges in medical device development and manufacturing.