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.

Sign-up

Sign-up for email updates and our exclusive free MDR downloads.

You will be subscribed to our email newsletter and be sent a link to access our downloads. You can unsubscribe at any time. Your privacy is important. See how we handle your data.

Any questions?

If you have any questions about our MDR services, please get in touch.

Or you can request contact from us and we will get back to you:

Request contact

Download our free Mastering the MDR White Paper — Our easily digestible summary of the EU MDR

Download

MDR Training

Our comprehensive training solutions are delivered by experts and address all aspects of MDR compliance.

Do you have any questions about our services or training?

Contact us