Clinical Evaluation Report
All sorts of medical devices may be required to submit a Clinical Evaluation Report (CER), which summarises the clinical evaluation procedure. All inputs from risk management, verification testing, literature reviews, and clinical research are analysed in the CER. Based on the intended use and the manufacturer’s claims, the goal is to ascertain if there is sufficient clinical data to support the safety and effectiveness of the medical equipment.
What Patient Guard Can Help With
- Write your CER
- Update your existing CER
- GAP-analysis of your current CER
- Upgrade your existing CER
- CEP / CER Training
- Clinical Expert Review
It is acknowledged as one of the most time-consuming and difficult processes for medical device manufacturers to write an EU MDR Compliant Clinical Evaluation Report.
The CER over the course of a product’s life cycle
The original CER is created while your technology is in the development stage and is needed in order to get market approval. It must be continually updated following market release to take into account information from post-market surveillance, any newly identified hazards or indications, and advancements in the clinical community.
Expertise
Patient Guards experts can evaluate if a clinical evaluation report is acceptable to the Notified Body or local authority and can recognise a good clinical evaluation report. Our crew is capable of assisting any medical manufacturer because of their vast experience in data analysis, medical writing, and CER writing.
