We advise our clients regarding current and upcoming standards, regulations and requirements in international markets, including the EU Medical Device Regulation (MDR 2017/745).
Our International Regulatory Compliance Services
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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)
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Labeling Review:
MCRA can review product labeling, icluding IFU, device labels, and promotional materials for completeness and market compliance
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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
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Risk Management:
Develop compliant risk management procedures including, risk management plans and risk analysis in compliance with EN ISO 14971 (2012)