Performing an MDR Gap Analysis is essential when transitioning a device’s regulatory framework from the out-going Medical Device Directive (MDD) to the new Medical Device Regulation (MDR) 2017/745. Undertaking an MDR Gap Analysis will enable the identification of any gaps in the clinical evidence portfolio, allowing measures to be taken to address these gaps before engaging a regulatory body.
Our MDR Gap Analyser tool will enable you to objectively evaluate your regulatory strategy against MDR requirements:
www.mantrasyst...
We also have an EU MDR Compliance Guide that walks you through the entire Medical Device Regulation, including Gap Analysis:
www.mantrasyst...
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