Anouk van der Gracht
Quality assurance / Regulatory Affairs Manager & Medical Device Consultant
Anouk has always had an interest in innovation in the life sciences and medical technology. This interest drove her to completing her master in life science and technology and contributing to science in the form of a PhD in chemical immunology. She has obtained her doctoral degree at the faculty of science in Leiden. After her PhD she has started in the field of QA/RA for medical devices. She has been trained on ISO 13485, ISO 14971, IEC62304 and ISO 19011. Anouk is experienced in application of risk management, management review and MDR regulatory requirements for medical devices. Furthermore, she is experienced in her role as consultant for support of technical documentation for medical devices and quality system maintenance and set-up. As QA/RA manager she is responsible for ensuring that the quality demands set by regulations are met for the medical device software applications Peercode makes. Together with the quality team she maintains the quality management system of Peercode and strives to improve this continuously. Quality is not just about checking the boxes that regulations are met, but more so to ensure an efficient (documented) design process where the intended use and the benefit for the patient are of utmost importance.