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