Medical Device CE Marking Consultant(s)

As part of the CE Marking process, Medical Device Technical File will be reviewed by Notified Body experts for supporting evidence in compliance to essential requirements. The help of an experienced Medical Device CE Marking consultants like I 3 CONSULTING will make the CE Marking path easy by preparing and and re-submitting the Technical File to Notified Body untile the client gets CE Certificate.

I 3 CONSULTING team of Consultants, highly qualified and experienced in various type and class of medical device only can successfully guide you through the entire process of Medical Device CE Mark(ing).

Below detailed the major reasons why an experienced CE Marking Consultant is recommended for Medical Device CE Mark Certification.

  • Medical Device CE Marking Consultants can understand your device and its applicable regulatory requirments faster than anyone.
  • CE Marking Consultants must always have prior experience in handling similar Medical Devices
  • Guidance and support in preparing Technical File
  • Medical Device CE Marking Consultants have experienced medical writers for the preparation of Clinical Evaluation Report as per MEDDEV 2.7/1 Rev. 4
  • Support in conducting Risk analysis
  • Quality Management System implementation as per ISO 13485:2016
  • Identify the applicable Harmonized standards
  • CE Marking Consultants have the necessery knowledge to Verify the external test report
  • Verification of Validation documents
  • Medical Device CE Marking Label Review as per ISO 15223-1
  • Identifying the class of Medical Device
  • CE Marking Consultants identify the main route of CE Marking
  • CE Marking Consultant will prepare the Declaration of Conformity
  • Identifying the Notified Body
  • Support during Certification audit
  • Others like
    1. Proper guidance on complicated devices like Animal Origin products
    2. Technical support for critical equipments like Radiation equipments.
    3. Electro-Mechanical Devices  as per 2007/47/EC
    4. Software CE Marking

Our CE Marking Consultants capable of handling Drug-Device combination products!!!

Advantages of appointing CE Marking Consultants from team I 3 CONSULTING

  1. Worldwide team of CE Marking Consultants
  2. Largest customer base  in Asia for CE Mark & FDA 510k
  3. Our CE Mark Consultants can handle any critical medical devices.
  4. Technical File, Testing, Notified Body & EAR Service - All in ONE!!!
  5. Onsite & Offsite (online) consultancy with very normal fee

Any additional clarification kindly contact us

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