QMedCo Clinical Evaluation consultancy services
The Clinical Evaluation Report (CER) is a pivotal document submitted to the Notified Bodies under MDR. It serves as a comprehensive assessment of a medical device's safety and efficacy. The analysis and appraising of all clinical data forms the basis for the CER and it ensures that the device performs as intended and poses no unexpected harm to patients or users. This critical evaluation aids in determining whether the device meets the stringent regulatory requirements and safeguards public health.
Clinical Stage services
Data Analysis & Appraisal
Through meticulous examination and interpretation of clinical data, these processes provide valuable insights into a medical device's safety, efficacy, and performance. They help identify potential risks, benefits, and adverse events associated with the device, ensuring its compliance with regulatory standards.
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Clinical Evaluation
Report
More than 60% of the medical device industry outsource the writing of the CER attributed to their lack of internal expertise which is specifically the case for start-ups and SME. This outsourcing has implications for their resources. A CER needs to be assessed to comply with all MDR requirements before submitting it to the Notified Bodies to avoid unnecessary delays.
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