Dr. Kirsten Theiling is Quality Management Representative and an expert in quality management and regulatory affairs with a focus on IVDs and medical devices. She has established and maintained quality management systems in accordance with ISO 13485, ISO 9001 and 21 CFR Part 820 at various manufacturers and holds the qualification as a Person Responsible for Regulatory Compliance (PRRC). Her expertise is grounded in a doctorate in biology and extensive leadership experience in quality management and regulatory affairs departments within the medical device industry.