Our International Regulatory Compliance Services

  • 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)


Contact a Regulatory Affairs Expert