CE Mark Consultants

The consultant can be selected by their knowledge in the field, education which suit the requirement, the consultants skill about demonstration of compliance to the requirements of the standard or directive and qualification of the consultant.

In product certification, being it is very technical area, the consultant must be selected who has the complete knowledge about your products or similar products, this knowledge is beneficial in identification of applicable standards and wherever necessary in demonstration of the compliance with the applicable standards which may be generic, collateral or particular in nature
the consultant must be aware about the quality management system requirements at the same time the product certification requirements. This is because, CE marking is a combination of product certification and it also include the route of conformity assessment through the implementation of the quality management system as per the applicable harmonised standard
Below mentioned are the major reasons why an experienced CE Mark consultant is recommended for Medical Device CE mark Certification.

  1. Better understanding of Medical Device
  2. Previous experience of consulting similar Medical Devices
  3. Guidance and support in preparing Technical File
  4. Clinical Evaluation as per latest standard
  5. Support in conducting Risk analysis
  6. Quality Management System implementation as per ISO 13485:2003
  7. Identify the applicable Harmonized standards
  8. Verify the test report
  9. Verification of Validation documents
  10. Label Review
  11. Identifying the class of Medical Device
  12. Finding the route of CE Marking
  13. Prepare the Declaration of Conformity
  14. Identifying the Notified Body
  15. Support during Certification audit
  16. 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

in AVS certification services, you will find the consultants understand your technical language, they understand the standards language and they can also interpret the requirements of the particular standards and the requirement of the directives which are applicable to your product.

Contact us

A1-101, Ankur,
Near Cipla Foundation,
Warje, Pune- 411058

E mail :- info@avscertification.com
Telephone :- +91 - 9881946595

Design & Developed By : Logic Palace Systems and Softwares
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