CE Marking Certification for Medical Devices.

 

CE certification is required for medical devices to demonstrate that your medical device meets the requirements of the Medical Device manufacturer by carrying out a conformity  assessment. It depends on the classification of medical device.

The steps for CE certification process for medical devices is as follows: 

·   Classification 

·   Applicable directive 

·   Technical documentation  

·   Certification. 

CE mark Approval process will vary according to the Class of medical device, as per the MDR CE marking Approval consist of few more things such as product quality, technical dossier submission to NB, clinical evaluation and so on. Many medical device manufacturers don’t really read the regulations of EU MDR and they get stuck somewhere in the process, which may delay the project to avoid that you need to know where to start and who is right CE marking consultant for you.  

Operon strategist don’t leave you behind, we make sure that our client should get the CE approval with minimum efforts