Activity

Class Is/Ir/Im

Class IIa

Class IIb

Class III

• Review of Risk File
• Review of Post Market Surveillance Data
• Review of PMCF data
• Development of PSUR
• Literature Search and reporting
• IFU review and suggestions
• Review of Clinical investigation and retrospective data submitted by the customer

$ 7000

$ 9000

$ 11000

$ 13000

• Review of Risk File
• Review of Post Market Surveillance Data
• Review of PMCF data
• Development of PSUR
• Literature Search and reporting
• IFU review and suggestions
• Review of Clinical investigation and retrospective data submitted by the customer
• Notified Body submission and document updation and response.

$ 10000

Additional Services

• Technical Documentation without NB coordination

+ $6000

• Technical Documentation with NB coordination

+ $8000

• Clinical investigation/retrospective study