Service
Supplier Quality Management
Effective supplier quality management is critical to ensuring the reliability, safety, and compliance of medical devices. UpShot supports manufacturers in qualifying, auditing, and monitoring suppliers to maintain high-quality standards, reduce supply chain risks, and ensure regulatory readiness.
Comprehensive SaMD Support
UpShot partners with medical device manufacturers to build and maintain robust supplier quality systems that meet the highest regulatory and industry standards, including ISO 13485 and FDA QSR. From supplier qualification and onboarding to ongoing performance monitoring and audits, we help ensure that every component and service in your supply chain contributes to safe, effective, and compliant products. Our expertise supports risk-based supplier management, strengthens traceability, and reduces the likelihood of costly disruptions—enabling manufacturers to maintain control and confidence in a global supply network.
Our Service Includes
Supplier Lifecycle Management
Identification, selection, qualification, ongoing monitoring, and disengagement of suppliers based on performance, compliance, and business needs
Capability Assessments
Evaluation of new and existing suppliers for technical competence, manufacturing capabilities, and quality system maturity.
Process Validation Support
Collaboration with suppliers to characterize, qualify, and validate new or improved manufacturing processes to ensure consistent output.
Cross-Functional Issue Resolution
Coordination with Procurement, R&D, Engineering, Quality, Operations, and Suppliers to investigate, resolve, and prevent supplier-related issues.
Performance Monitoring & Risk Control
Implementation of supplier performance metrics, quality issue tracking, and risk management strategies to ensure supply chain reliability.
Supplier Change Management
Oversight and control of supplier-initiated changes through a structured change control process to prevent unintended impacts.
Supplier Quality Agreements
Development and maintenance of formal agreements that clearly define quality responsibilities, expectations, and compliance obligations.
