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Zuzanna Kwade

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Zuzanna Kwade is Medical Affairs Manager, Agfa Healthcare. Zusanna holds a PhD in Biochemistry and has more than ten years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research.
Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represents COCIR in the European Union Task Force on clinical evaluation of software.

Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

17-19 Nov 2020

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

28-30 Apr 2021

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

5-7 May 2021

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

27-29 Oct 2021

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

Medical Device Software: Complying with the MDR (Medical Device Regulation) & FDA (Food and Drug Administration) Regulations Training Course

Medical Device Software: Complying with the MDR & FDA Regulations

3-5 Nov 2021

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.