Thu, 09/18/2014 - 14:29
The regulatory landscape continues to change. One of the quality system approaches defined by regulators and the industry for mitigating risk is corrective and preventive action, better known as CAPA. Companies are often challenged by the CAPA…
Edna Falkenberg
Manager of quality and R&D
Edna Falkenberg is the manager of quality and R&D for TÜV SÜD America’s Medical Health Services Division. She joined TÜV SÜD in 2011 as a lead auditor for active medical products. Her previous experience includes 10 years at Karl Storz GmbH & Co. KG beginning as manager of regulatory and standards compliance, advancing to special projects and environmental compliance engineer, and finally director of quality systems and regulatory affairs. Falkenberg has a bachelor of science in biomedical engineering from University of Applied Sciences, Lübeck (Germany). TÜV SÜD America services include auditing, expert clinical and biomedical engineering reviews, electrical, functional safety, and biocompatibility testing.
Thu, 09/18/2014 - 14:29