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Morten Purup Andersen

Senior Human Factors Specialist
Morten purup hansen, writer of FDA submission article
More about Morten
Morten Purup Andersen has a M.Sc. degree in Engineering Psychology from University of Aalborg, focusing on human interaction with User Interfaces. Morten is an experienced Senior Human Factors Specialist and has worked with a broad range of international medical device and pharma manufacturers. He has vast experience within Medical Devices, Home-Use Medical Devices, Single-Use Medical Devices, In-Vitro Diagnostic, Implants, Combination Products, Radiopharmaceuticals, Electronic Medical Records, Software & IT, Web and Mobile and Consumer Electronics. In addition to his strong expertise within Human Factors and Usability Engineering, Morten is skilled and experienced in Risk Management and Design Control within Medical Device development. Furthermore, Morten has a deep knowledge of the regulatory aspects of Usability Engineering as it relates to Design Control and Risk Management as well as successful experience interacting with regulatory authorities, including notified bodies and FDA. Morten is experienced in all phases of medical device development; from concept to post-market surveillance. Therefore, he can offer consulting in all development phases.

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