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The first step in preparing for the creation of a compliant medical device is the gap analysis. This comprehensive assessment, conducted by professional analysts, like the team of CCLab, aims to examine the conformity of products to the relevant MDR paragraphs. If nonconformance occurs, an all-encompassing summary is created for the vendor and manufacturer about what needs to be done and changed to attain the requested standards.
This downloadable infographic guides you through the gap analysis process to properly prepare for the certification, which can significantly decrease the chances of failure.