This recorded session provides an essential overview of the requirements of clinical evaluation as mandated by the MDR. The trainer provides practical examples for different types of devices (e.g. implants, software) and covers determination of sufficient level of clinical evidence, literature screening and a clinical evaluation report (CER) writing.
By the end of this TRIUM Training you should be able to:
- To evaluate the potential gaps in your organization related to clinical evaluation and CER development or required updates to comply with the new MDR requirements
- To determine an action plan based on relevant requirements and processes to conduct clinical evaluation and produce a CER
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.