Clinical

Clinical Evaluation of Medical Devices ›

Clinical evaluation is a key process in the medical device lifecycle. It begins at the very start of device development and continues throughout its entire lifetime. The aim is to ensure and demonstrate that the medical device is safe and performs as the manufacturer claims.

Clinical Support for Your Medical Device

Medical devices play a crucial role in delivering healthcare services. Given their significant contribution to patients’ health, these devices must be safe and effective. This necessity has led to various regulations and standards that establish the framework for safety and performance requirements, particularly from a clinical perspective. Navigating these requirements can be challenging and demands specialized knowledge and experience.

What can we do for you?

Our medical device team has extensive experience and expertise to support you with:

  • Clinical evaluation
  • Clinical investigation (regulatory) compliance (ISO 14155 support)
  • Literature searches for medical devices
  • Post-Market Clinical Follow-Up
Konstantin Simočenko
Senior RA Manager

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Konstantin Simočenko
Senior RA Manager

Let's Connect

Talk to an expert