Clinical Evaluation

Clinical evaluation is ‌a systematic process to continuously assess the safety and performance of a medical device.

Done correctly, it is an holistic process that is fed by results from Risk Management, PMS, PMCF, Vigilance, and the Quality Management System.

High-quality Clinical Evaluation requires a range of skills that draw upon the expertise of our medical professionals — systematic literature review, the assimilation of a range of different clinical evidence types, critical appraisal, advanced data interpretation, and accurate expression of conclusions.

The Clinical Evaluation is summarised in a Clinical Evaluation Report (CER), an important technical document. A CER is required for MDR compliance which is necessary before the May 2021 deadline in order to secure device certification after this date.

Our services include:

  1. Performing a 360-degree Clinical Evaluation of any medical device in accordance with Annex XIV Part A MDR.
  2. Writing and reviewing Clinical Evaluation Reports (CERs).
  3. Preparing towards Clinical Evaluation by performing a systematic literature review, appraisal, and Gap Analysis.
  4. Developing and documenting a clinical development plan.
  5. Designing and implementing clinical investigations to apply the clinical development plan in addressing evidence gaps.


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