About Garza MD - Garza MD

Garza MD is the independent Consultancy Agency of Ninke Bourgonjon.

Photography: Jos Hummelen, ROM Utrecht Region

Trained as a technical designer (Master of Science in Industrial Design Engineering, Delft University of Technology), she increasingly developed herself as a QA specialist in the past years, with a passion for medical products of superior quality, simple usability and outstanding performance and results. She has extensive expertise in the design and development of medical devices, set-up and maintenance of Technical Files, requirements engineering, product and process risk management, usability engineering, quality management system development and implementation, coordination of clinical evaluations, auditing, training & coaching.

She has an analytical mind, a strong affinity with the whole, the big picture, and a human centred approach. She has proven to be able to facilitate in organizations to overcome a natural resistance against rules and regulation.

She has extensive (> 10 yrs) experience with safety critical design and quality assurance throughout the entire development life cycle of medical devices, including the CE marking process and regulatory submissions in Canada and Australia. Her background is in software and hardware for active medical devices in different areas of the medical field (radiology, radiotherapy, kidney dialysis and patient lifts).