Boris Lux is a Quality Assurance and Manufacturing Engineering Consultant with a robust background in medical device development and quality management. They held significant roles at JenaValve Technology GmbH and biolitec AG, focusing on risk management and regulatory affairs across the product life cycle. With a Ph.D. in Physics from the Technical University Dresden, Boris has contributed to the CE mark approval process and ensured compliance with quality system requirements in various international environments. Currently, they work as a Risk Management & Regulatory Affairs Expert at Accurity, supporting multiple aspects of quality assurance and process validation.
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