Aida Ilkhechoie

Aida Ilkhechoie is employed as a Senior Quality Assurance and Regulatory Affairs consultant at Key2Compliance® and has more than 10 years of experience in the Medical Device industry.

Aida has during these ten years worked to build, implement and certify quality management systems according to ISO 13485 and participated in several R&D projects acting as the project leader with the responsibility for identifying the regulatory requirements for CE marking the product and setting up the Technical documentation.

She has experience of a CE marking a variety of medical devices and in-vitro diagnostic devices, with special expertise in CE marking Software as a medical device (SaMD) and guiding IT health service providers for the fulfillment of the regulatory requirements in LVFS 2014:7 (NMI), LVFS 2003:11 and applicable standards.

Aida holds a B.Sc in medical engineering from Royal Institute of technology, KTH, and is an active member of the Swedish standardization committee TK-344 Health informatics.



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