This executive summary encapsulates the key insights presented in our whitepaper, which delves into the critical realm of robust risk-benefit analyses within the context of Clinical Evaluation Reports (CER), Post-market Surveillance (PMS), and Post-market Clinical Follow-up (PMCF) activities for medical devices.
The whitepaper highlights the significance of risk-benefit assessments in ensuring patient safety, regulatory compliance, and the effective lifecycle management of medical devices. It discusses the key methodologies and best practices for conducting these analyses, emphasizing the need for evidence-based decision-making and continuous evaluation throughout the device’s lifecycle.
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