CE Mark Consultants

Due to the complexity of the medical device and various models makes the process of
CE Marking more complicated. Highly qualified consulting team with experiences in
CE Mark certification of medical device only can successfully guide you through the entire process of CE Mark.

Below mentioned are the major reasons why an experienced CE Mark consultant is recommended for Medical Device CE mark Certification.

  • Better understanding of Medical Device
  • Previous experience of consulting similar Medical Devices
  • Guidance and support in preparing Technical File
  • Clinical Evaluation as per latest standard
  • Support in conducting Risk analysis
  • Quality Management System implementation as per ISO 13485:2016
  • Identify the applicable Harmonized standards
  • Verify the test report
  • Verification of Validation documents
  • Label Review
  • Identifying the class of Medical Device
  • Finding the route of CE Marking
  • 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 Mark Consultants are capable of handling Drug Device combination products!!!

Advantages of appointing CE Mark Consultants from I 3 CONSULTING

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

Any additional clarification kindly contact us

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INDIA – Bangalore
+ 91 994 591 2081
Phone / Viber / WhatsApp

USA – Chicago
+1 630 696 1293
Phone / Viber / WhatsApp

mail enquiry@i3cglobal.com

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