Our Integrated Approach

New EU MDR - Perform gap analysis on current technical documentation and processes to identify gaps and deficiencies and assist with transition to MDR compliance. (see link for details)

Labeling Review - MCRA can review product labeling, icluding IFU, device labels, and promotional materials for completeness and market compliance 

Post-Market Surveillance/Post-Market Clinical Follow-Up (PMCF) - Develop procedures in compliance with county specific post-marketing surveillance requirements including PMCF protocol development and statistical plans 

Risk Management - Develop compliant risk management procedures including, risk management plans and risk analysis in compliance with EN ISO 14971 (2012)


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Dave McGurl

Dave McGurl

Director, Regulatory Affairs