Quality Policy
At Organ Recovery Systems, our mission is to honor organ donation by delivering innovative solutions that support transplant professionals and improve long-term outcomes for patients.
To fulfill this mission, we are committed to::
- Designing, developing, manufacturing, and supporting safe, effective, reliable, and compliant organ preservation and transplant technologies.
- Maintaining an effective Quality Management System that complies with applicable regulatory requirements, international standards, and customer expectations.
- Applying quality and risk-based principles throughout the product lifecycle and using measurable quality objectives and performance data to improve the effectiveness of the Quality Management System, product quality, and customer satisfaction.
- Collaborating with customers, suppliers, regulatory authorities, and other stakeholders to advance innovation while ensuring product safety, performance, and regulatory compliance.
- Providing the resources, training, and organizational culture necessary for employees to uphold our values of Innovation, Collaboration, Accountability, and Integrity in all activities.
Through these commitments, we strive to ensure that transplant professionals can rely on our products with confidence and that every donated organ entrusted to our technologies has the greatest opportunity to benefit patients.
Regulatory and Client Service Resources
LifePort Kidney Transporter Products
Lithium Ion Battery UN IATA 38.3 Certificate
Product Operator’s Manuals and Instructions for Use
Organ Recovery Systems
Product Operator’s Manuals and Instructions for Use
Terms and Conditions
Limited Product Warranty
Product Security
The LLT Software Bill of Materials (SBOM) can be provided upon request
Registrations and Certifications
Organ Recovery Systems MDSAP Certificate
Organ Recovery Systems ISO 13485:2016 Certificate
Organ Recovery Systems FDA Regulation Number
Organ Recovery Systems EC Certificate