Marianne Le

Design Control Specialist
More about Marianne
Marianne holds a master’s degree in chemical engineering and has worked in the medical device industry since 2014. She has worked with new product development of both medical devices (MD) and in-vitro medical devices (IVD), and she has in-depth experience with requirement engineering, test method development and validation, and design verification and validation. She has also supported life cycle management projects, e.g., transition from European medical device directives to regulations (MDD to MDR and IVDD to IVDR). She truly believes that design control is more than “just documentation and regulation”. As a scientist she has experienced that design control is a crucial tool in excellent product development, which is why she is a strong advocate for the integration of design control timely in development projects. She is diligent and a strong team player who has worked in different sized companies, which has made her very adaptable to different quality levels, and although she holds herself to a very high work standard, she is pragmatic and always finds solutions that meet cross-organizational demands.

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