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At A Glance The project focused on launching a new advanced medical drilling system aimed at enhancing surgical precision and effectiveness. Spearheaded by a leading medical device manufacturer, the project included a rigorous Production Part Approval Process (PPAP) to ensure all components adhered to the highest quality and safety standards. This project represented a significant […]
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Precision in Transition: Mastering Complex Line Transfers in Medical Device Manufacturing
At A Glance Performance Validation (PV) was enlisted by a renowned Michigan-based medical device manufacturer to facilitate a complex and strategic relocation of eight production lines. This project involved transferring the manufacturing of ear, nose, and throat (ENT) single-use, sterile devices to a newly established facility in Kalamazoo. The primary goal was not just the […]
Read MoreStartup Medical Device Manufacturing Facility – Establishing the Quality System
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 MoreMedical Device Manufacturing Facility – Quality System Enhancement/FDA Response
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 MoreNew Medical Device Production Line
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 MoreMedical Device Manufacturing Facility – Medical Device Quality System Improvement
The 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 […]
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