Monday 2 January 2012

CE Mark Consultancy Bangalore


The following are the major reasons why a consultant is recommended for Medical Device CE Certification
  1. Previous experience of certifying similar or related equipments /products
  2. Documentation support including Technical File
  3. Clinical Evaluation as per latest standard
  4. Support in conducting Risk analysis
  5. Internal Audit
  6. Identify the Applicable Harmonized standards
  7. Verify the test report
  8. Verification of Validation documents
  9. Label Review
  10. Identifying the class of Medical Device
  11. Finding the route of CE Marking
  12. Prepare the Declaration of Conformity
  13. Identifying the Notified Body
  14. Support during Certification audit
  15. Others like

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2 comments:

  1. Mahi Ahuja9 May 2016 at 03:34

    Nice information on the importance of CE marking for medical products..I found this article very useful..thanks for sharing..!

    ISO Certification in Bangalore

    ReplyDelete
  2. Unknown15 June 2016 at 03:40

    Nice post on the reasons for the CE certification for any product..thanks for sharing.
    ISO Mnagement System in India

    ReplyDelete

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