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Medical Device Clinical Evaluation Report(s) as per Meddev 2.7/1 Revision 4

The Clinical Evaluation Report (CER) as per MEDDEV 2.7.1 Rev 4  is considered a tool to provide Notified Bodies with a complete overview of the continuous clinical evidence of safety and performance of the medical device. During the clinical evaluation process, all data that could provide information on the clinical safety and performance of the device is analyzed and assessed.
Due to this reason developing and maintaining Medical Device Clinical Evaluation Reports (CER) became a higher priority for CE Marked Medical Device manufacturers across the globe.

A good Medical Device Clinical Evaluation Report (CER) should support strong clinical evidence that your device achieves its intended purpose without exposing users and patients to risk. The Clinical Evaluation Report (CER) must be based on clinical data, which may include clinical data from existing literature, clinical experience, clinical trials, or any combination of the three.
Compared to earlier Rev 3, MEDDEV 2.7/1 Rev 4 has some more requirements that are very difficult to interpret and those new. It may cause delays in the Notified Body review process if just updating based on literature strategy without Equivalence device analysis will increase your risk of rejection of Clinical Evaluation Report by Notified Bodies.

We offer the right strategy starting with GAP analysis of your existing Medical Device Clinical Evaluation Report.  If required  we are here for you to take up the job for updating your present Clinical Evaluation Report or develop a new Clinical Evaluation as per Meddev 2.7/1 Rev. 4.

   
Benefits of CE Marking Medical Device Clinical Evaluation Documentation Services:
  • We support small and large organization. No matter the type of organization is.
  • Dedicated team of 26+ experienced consultants spread in three different locations ( USA, Germany & India)
  • Strong experience in all various type of devices ( Class l, Class ls/m, Class lla, Class llb & Class ll)
  • Documents are developed in cloud, so customers can monitor progress every moment.
  • Economic & Fast ( Normally projects completed in 60-90 days)
  • Project Handover after Notified Body approval ( We newer leave you in dark)
  • Friendly consultants.
  • Payment based on progress.

Some of the questions answers you can find from the below useful links.

Clinical Evaluation documentation fees as per Meddev 2.7/1 Rev 4 (Click here>>)
Existing Medical Device Clinical Evaluation Report GAP analysis (Click here>>>)
Download an useful article about Medical Device Clinical Evaluation Report (Click here>>)

If you need more information about Medical Device CE Marking Clinical Evaluation Report(s) as per Meddev2.7/1 Rev 4, please write to enquiry@i3cglobal.com. Our team will understand more about your device and guide you accordingly.

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