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This whitepaper presents the new MDR requirements regarding PMS obligations and the risks resulting from their implementation in a global QMS.
In this white paper, take a look at MDR 2017/745 and how it will impact medical device manufacturers.
This white paper references the EU-UK Trade Agreement signed in December 2020 and the available guidance documents to provide a roadmap for marketing medical devices and IVDs in the UK post-Brexit.
In this white paper, we'll show you how to navigate FDA databases testing standards and guidances related to your device.
In Europe, certain in vitro diagnostic (IVD) devices must undergo clinical performance (CP) evaluation studies conducted in accordance with current regulations in order to obtain CE Marking.
In this white paper, learn about PMCF studies in the context of the change from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU).