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Clinical Evaluation Report (CER) Annual Updates

Have you ever created a Clinical Evaluation Report?
If your answer is “yes”  ,please answer the below.

  1. As per which guidelines?
  2. When was the last updates you made?
  3. Did your Notified Body made any serious remarks on your CER?

If your answer is  “NO” it’s time to think about preparing a new CER. Click here >>

Notified Body always insist to have updated CER before annual QMS surveillance audit. We recommend hiring the service of consultants like us to help manufactures to save time and substantial amount of labor while keeping in mind that unpreparedness at audit time carries a variable amount of risk of suspension of CE Certificate

Preparing a Clinical Evaluation Report (CER) is time-consuming and require deep passion and skill. A post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). Depending upon the nature of your device and the amount of clinical history you have with that device, you may also need to conduct a post-market clinical follow-up study (PMCF). Any post-market surveillance that you conduct should be included as an input to the clinical evaluation report. You need to consider a significant modification to the device function, design, or materials before updating the CER.

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