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ISO 13485 Certification Cost

EN ISO 13485 Certification Cost depends on various factors such as (a) Number and Type of Medical Device manufactured (b) Shop Floor Area, (c) Number of employees (d) Certification Body selected etc.

EN ISO 13485 Certificate Consultant

ISO 13485 Certification Quality Manual, Mandatory Procedures & Templates

  • Drafting Quality Manual for your Organization: $ 450.
  • Drafting Mandatory Procedures: $ 850.
  • Drafting Important Templates: $ 350.
  • Generally, one full set of document drafting after a thorough
  • Understanding your company & processes will take approximately 14 -20 working days.

ISO 13485 Certification On-site Interaction with process owners and Guidance

  • On-site Interaction with process owners and Guidance
  • ON-SITE visit : $ 400 USD / man-day
  • Travel & Accommodation will be charged on actual.
  • The number of consulting man-days depends on the organization and
  • The skill of the person interacting with the consultants.
  • An average of 5-6 man-days is estimated for a small organization with
  • 10-15 employees.

ISO 13485 Certification Training’s & Internal Audits

  • On-site Interaction with process owners and Guidance
  • ON-SITE visit : $ 400 USD / man-day
  • Travel & Accommodation will be charged on actual.
  • The number of consulting man-days depends on the organization and
  • The skill of the person interacting with the consultants.
  • An average of 5-6 man-days is estimated for a small organization with
  • 10-15 employees.