The new EU MDR is the most significant revision to date and contains several key changes that will greatly impact how medical device companies are working with their product data, documents and technical files today.
Yet, according to a 2018 survey made by KPMG, “58% of regulatory and quality leaders from more than 200 medical device companies do not have a strategy in place to remediate gaps in their clinical data or processes for collecting data”.
Medical device companies should improve the visibility and traceability of their product data, documents and technical files.
This is simply the most efficient way to ensure that your data is ready for the EU MDR.
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