Case Studies – Performance Validation

Startup 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 […]

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 […]

Production line with workers at medical facility

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 […]

Medical 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 […]

Alex Wegner

Med Devices Services Manager - Alex has over eight years of experience in medical devices and manages the validation and PPAP teams. He has vast experience with developing and executing equipment qualification, test method validation, and process validation documents to ensure they meet the quality system and regulatory requirements. He has led multiple large validation projects that have ranged from new manufacturing lines to transferring product lines from one site to another.

Schedule with Alex Wegner

Category: Medical Device

Startup Medical Device Manufacturing Facility – Establishing the Quality System

Medical Device Manufacturing Facility – Quality System Enhancement/FDA Response

New Medical Device Production Line

Medical Device Manufacturing Facility – Medical Device Quality System Improvement

Alex Wegner