Clinical Evaluation (CER) & Post‑Market Surveillance (PMS) Services

Prove safety and performance. Stay compliant. Protect patients.
I help medical device manufacturers build, maintain, and defend Clinical Evaluation and Post‑Market Surveillance evidence across the device lifecycle—efficiently and audit‑ready.

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Why this matters

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• Regulatory necessity: EU MDR 2017/745 / IVDR 2017/746, UK requirements, and US FDA QMSR demand robust clinical evidence and continuous post‑market monitoring.

• Patient safety & performance: Demonstrable, current, and traceable data keeps your device safe and effective in real‑world use.

• Market access & continuity: Strong CER/PMS underpins CE/UKCA marking, US marketing, and successful Notified Body and authority reviews.