Article | May 14, 2019

Preparing For MDR? Start With A Gap Analysis

Source: WuXi AppTec

By Mark Cabonce

Preparing For MDR? Start With A Gap Analysis
A gap analysis looks at pre-existing data and product portfolios to identify where there are holes in the information under new regulatory requirements. Image courtesy of WuXi AppTec.

With the EU Medical Device Regulation (MDR) going into effect in about a year, medical device manufacturers are gearing up to prepare product lines for the massive regulatory changes. The planning and pre-clinical testing necessary for MDR compliance can be an exhaustive, multi-faceted venture. But starting with a gap analysis can help ease the process for OEMs.

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