Stefan Klein

Stefan Klein is a medical device expert with over 25 years of experience in Quality and Regulatory Management Systems, specializing in ISO 13485, MDSAP, and FDA requirements. They currently own SK-Medtech Solutions and serve as a lead auditor for DQS Medizinprodukte GmbH while previously holding roles such as Director of Quality Management and Regulatory Affairs at Munich Surgical Imaging GmbH. Stefan has also contributed significantly to various organizations, including Edwards Lifesciences and ARRI Medical GmbH. They hold a degree in Medical Device Engineering from Hochschule München University of Applied Sciences.