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Project Manager IVD Medical Device Testing TÜV SÜD
Description: We keep noticing that similar mistakes are made by manufacturers when submitting the technical documentation for IVDR software devices.
In this session, various pitfalls regarding cybersecurity specific documentation such as risk management, security concept, security concept implementation, penetration tests, etc. should be discussed.
Also, a multi-step approach for integrating cyber security for an IVD medical device across the entire product life cycle will be addressed.
Learning Objectives:
Upon completion, participant will be able to describe the typical cyber security specific pitfalls regarding the IVDR technical documentation submission.
Upon completion, participant will be able to explain why it is essential to consider cyber security when designing, developing, and upgrading IVD medical devices across their entire life cycle.
Upon completion, participant will be able to name and explain the different testing levels which are crucial for the cyber security testing activities along the whole product life cycle.
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