Class II
Clinical evaluation update for a Class II transcutaneous spinal cord stimulation system in spinal cord injury
Annual update of the Clinical Evaluation Plan and Report, focused on the systematic literature review.
- Client
- Class II non-invasive transcutaneous spinal cord stimulation (TSS) system for spinal cord injury
- Work
- Clinical evaluation
- TSS
- Class II
Situation
A Class II non-invasive transcutaneous spinal cord stimulation system for spinal cord injury required its annual Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) update for the Notified Body. The systematic literature review had to be current and defensible under EU MDR.
Approach
We supported the annual CEP and CER update, with the work focused on the systematic literature review — search, appraisal, and how the evidence tied to the claims in the evaluation.
Outcome
An audit-ready CEP and CER on file for the Notified Body.