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Anouk van der Gracht

Quality control/ medical device manager

Anouk van der Gracht

Anouk’s role at Peercode is quality control/ medical device manager. As quality manager she is responsible for ensuring that the quality demands set by regulations are met for the medical device software applications Peercode makes. 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. Together with the quality team she strives to improve the quality management system of Peercode.

During her studies in Life Science and Technology (combination between TU Delft and Leiden University) her interest in innovations within the life sciences and especially the medical sector further developed. This interest in innovations drove her towards attributing her piece to science in the form of a PhD in chemical immunology. During her PhD her analytical skills were further developed/refined. Her background in life sciences enables her to aid in the communication of the clients wishes regarding medical content to her colleague software developers. 

Anouk is familiar with ISO norms such as ISO 13485, 14971 and IEC 62304, which are utilized at Peercode to ensure well structured technical files, which are easy to maintain and are compliant with regulations (most commonly MDD/MDR).

Visit our Peercode Regulatory Consultancy website for more information about our quality-, law- and regulatory-based services in the field of medical devices.

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