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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

Quality Manual, Mandatory Procedures & Templates

  • Drafting Quality Manual for your Organization: $ 650.
  • Drafting Mandatory Procedures: $ 1050.
  • Drafting Important Templates: $ 550.
  • In general, it takes 2 weeks to frame a full set of documents after receiving basic information from the manufacturer.

On site guidance and interaction with process owners

  • ON-SITE visit : $ 600 USD / man-day
  • Travel & Accommodation will be charged on actual.
  • The number of consulting man-days required is determined by the organization and ability of the individual who interacts with the consultants.
  • An average of 5-6 man-days is estimated for a small organization with¬†10-15 employees.

Off site guidance and interaction with process owners

  • Off Site / Online support : $ 350 USD / 4 Hours