Clinical evaluation and ISO 14971 risk management structured as a connected evidence chain — so risk files and clinical evidence support each other instead of being built in isolation.
What this covers
Clinical Evaluation Report (CER) development and structure
Benefit-risk framework construction aligned to intended use
ISO 14971 risk management file design and integration with design controls
Risk-to-evidence traceability across the product lifecycle
Literature review and clinical data strategy for evidence gaps
When this is typically needed
Building a CER for first EU MDR submission or periodic update
Risk management files exist but lack traceability to clinical evidence
Preparing benefit-risk documentation for Notified Body review
Expanding intended use or indications requiring updated clinical evidence