The Challenge A large Multi-National Medical Device company was seeking to expand manufacturing operations in Asia. This new manufacturing site located in China, needed to develop and implement a complete quality system, and satisfactorily complete local and corporate audits in preparation for facility startup. The Solution Performance Validation provided consultants to assist the client team […]
Read More
The Challenge A Fortune 500 Class 2 – Medical Device Manufacturer had received an FDA warning letter and was seeking assistance to correct the identified observations. The Solution Performance Validation (PV) provided a dedicated team of specialists in Production and Process Controls, Process Validation, Computer System Validation, Cleaning Validation, Laboratory Equipment, and Methods Validation to […]
Read More
The Challenge A Fortune 500 medical technologies firm wanted to increase the production capacity for its products. The intention was to increase capacity with a new production line that was also prepared for future products to be added to the line with minimal changes. This plan saw the addition of a new SCADA controlled production […]
Read MoreThe Challenge A large mid-western Medical Device company responding to multiple FDA inspections had not made adequate progress towards remediating their quality systems. The company had several hundred products that required remediation and a deadline of 18 months to complete this work. The Solution Performance Validation provided a dedicated consultant who participated with the client’s […]
Read More
Skip to main content