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EU MDR Implementation: Are you prepared?

EU MDR planning is a classic project management activity to identify what has to be done, in what order, by whom and by when, and how progress will be monitored. Every project will vary...it's not possible to create one implementation plan applicable to all organizations.

This paper offers guidance on practical aspects of the large undertaking of implementation and points out some of the major regulation changes, focusing on scope, new product development, quality management system, postmarket surveillance, labelling and more.

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