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31 March - 2 April 2020 // Nuremberg, Germany

This is what MedtecLIVE and MedTech Summit 2020 have to offer.

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MAJOR CHALLENGES: Regulatory Affairs

Risk management and their requirements tot he new EU MDR: what ist o be considered here Vortragssprache Englisch

Session: MDR - Practical Implementation

The general requirements of the risk management standards are presented and practical examples are given of how they should be used during development, implementation, validation, production and post market. Content: General structure of risk management Application during development Typical traps during development Application during validation Structure of the Post Market Surveillance Plan and which criteria have to be taken into account What are the specific requirements from the EU MDR (Article 88 and Annex III)? What do we do with the collected data? How does it become a Post Market Surveillance Report? The presentation will give an overview of the general structure of risk management and show how the critical factors have to be formed and tracked during development. In addition, typical traps are shown and how they can be avoided. It will be discussed how the critical factors must be handled during the process validation. The Post Market Surveillance Plan is seen as an important element in risk management and which requirements have to be covered in this plan (intended use, evaluation of risk, state of the art discussion and remaining risk). This section also discusses what the specific requirements from the EU MDR are and how they contribute to aggravating the situation. It will be discussed which data must then be collected during the market launch and how trends can be created in practice. Finally, it will be shown what happens with the collected data and how they are compiled into a Post Market Surveillance Report.

--- Date: 31.03.2020 Time: 11:30 - 12:30 Location: MedTech Summit Congress 2


 Malte Stöckert

Malte Stöckert

CEO / StingOrg GmbH


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