What is Post Market Surveillance and Lifecycle Compliance?

Maintain continuous regulatory compliance and product performance through a robust Post Market Surveillance (PMS) and lifecycle compliance framework aligned with FDA, EU MDR, and ISO 13485 requirements.

This service establishes and strengthens systems for complaint handling, vigilance reporting, CAPA, and post market data analysis ensuring that real world product performance is continuously monitored, evaluated, and fed back into the quality system. PMS systems are designed in accordance with EU MDR and FDA requirements (complaint handling, MDR reporting), ensuring global compliance coverage. Integration with risk management (ISO 14971) ensures that emerging risks are identified, assessed, and mitigated proactively.

Beyond compliance, the focus is on building a closed loop quality system where post market insights drive product improvements, regulatory updates, and sustained audit readiness. The result: a proactive, regulator aligned post market system that minimizes compliance risk and supports long term product success.