Overview

Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device to verify its clinical safety and performance. The evaluation is based on comprehensive analysis of pre- and post-market clinical data relevant to the intended use. This includes data specific to the device as well as any data relating to devices claimed as equivalent by the manufacturer. The whole process of clinical data evaluation is documented in a Clinical Evaluation Report (CER). The CER demonstrates that your device achieves its intended purpose without exposing users and patients to further risk. For all medical devices in Europe, which are submitted as an attachment to European CE Technical File, the CER is required.

Before preparing a CER, with emphasis on clinical requirements, Freyr assists manufacturers in developing a plan for the process. With strong EU medical devices regional expertise, Freyr caters to agency-wise requisites and customizes the CER accordingly. Freyr also assists device manufacturers in upgrading CER as per evolving regulations, providing expert review and conducting gap analysis of the report. 

Freyr Expertise

  • Upgrading existing CER to comply with the most recent Regulatory requirements
  • Gap analysis of current CER
  • Develop a clinical evaluation plan for medical device
  • Clinical expert review

Freyr Advantage

  • Assured compliance to recent applicable regulations
  • Team of qualified clinical experts
  • Cross functional inputs from medical device experts to comply with requirements
  • Full-scope service from compliance, review and planning