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Cost of CE Marking
- 1. Europe and U.S.A Medical Device Regulatory & Q A Consultancy Making the way of documents accepted by all regulators Making the path clears for early certification / approvals Making more savings to clients by providing very economic service from INDIA Making us to grow along with you Making excellence a habit
- 2. Class of Medical Device # Activity 1 1s/m 11a 11b 111 01 Guidance on MDD Requirements related to your Device Free Free Free 200 200 02 Identification of Class and Harmonized Standards 100 200 200 300 400 03 Preparation of Technical file / Design Dossier 600 800 1000 1200 1400 04 Support in closing NB reviewer comments 400 500 600 700 800 05 Label Review 100 200 200 300 300 06 European Union Representative Agreement Free Free Free Free Free 07 Additional Fee for Animal Origin Medical Devices 400 08 Additional Fee for Radiation Emitting Medical devices 600 09 OBL / PLM CE Certification Discount 10 % 20 % 20 % 20 % 20 % Fee mentioned above is in USD Payment Terms 50 % advance, Balance after completing the work Minimum Timeline 30 Days Agreement / MOU Will send from office after project confirmation Method of communication Telephone / Skype / G talk Document Storage Cloud Drop Box / Sugar Sync *Rate applicable for Europe and USA only More information Click here Interested? Download application form www.i3cglobal.com E Mail to – enquiry@i3cglobal.com India - + 91 80 5064 8432 USA - + 1 6030 270 2921