Gap Analysis and Remediation

The EU Medical Device Regulation (MDR) takes effect May 26, 2020. Are you ready?

Syncroness understands the new regulations and can perform a comprehensive gap analysis and qualitative review of your current technical documentation against the new MDR requirements. This assessment will determine what additional testing, analysis, etc. will be required to satisfy the new MDR requirements. In addition, we can provide the remediation and, if necessary, and design changes in support of the EU MDR update.

With over two decades in Medical Device product development, our engineering and quality professionals can help get you on track and start on the road to MDR compliance.


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