Service
Manufacturing & Operations
Efficient and compliant manufacturing is essential to bringing high-quality medical devices to market. UpShot helps manufacturers optimize operations, scale production, and maintain regulatory compliance through expert guidance in process design, validation, and continuous improvement.
Comprehensive Manufacturing & Operations Support
UpShot delivers end-to-end support for medical device manufacturing and operations, helping companies establish efficient, scalable, and compliant production environments. Our team works closely with clients to design and validate manufacturing processes, implement lean and Six Sigma methodologies, and ensure alignment with global standards such as ISO 13485 and FDA QSR. From technology transfer to process optimization and capacity planning, we help manufacturers reduce variability, increase throughput, and maintain consistent product quality—enabling faster time-to-market and sustainable growth.
Our Service Includes
Project Implementation Support
End-to-end assistance in executing manufacturing projects, including facility setup, equipment integration, and process deployment.
Process Optimization
Identification and implementation of improvements to enhance efficiency, reduce variability, and support lean manufacturing initiatives.
Statistical Process Control (SPC)
Conduct process performance studies using SPC tools to monitor, analyze, and control manufacturing processes for consistent output.
Commissioning & Qualification (IQ, OQ, PQ)
Execution of Installation Qualification, Operational Qualification, and Performance Qualification activities to validate equipment and process readiness.
Documentation Development
Preparation and continuous updating of essential manufacturing documentation, including Batch Records, Standard Operating Procedures (SOPs), and Work Instructions.
Manufacturing Control Plans
Development and implementation of control plans to ensure critical process parameters and product characteristics are consistently monitored and controlled.
