ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES



EN ISO 13485:2016 Fees

(Consulting, Implementation, Internal Audit, GAP Analysis, Training fees )

Medical Device Manufacturers ( OEM & OBL), Traders & Exporters across the Globe can avail our services.

Type of Service and Fees

[A] OFFSITE Custom made drafting of documents

  1. ISO 13485:2016 - Quality Manual & Mandatory Procedures with important templets in 20 working days - 1199 USD
  2. ISO 13485:2016 Quality Manual in 5 working days - 499 USD
  3. ISO 13485:2016 Mandatory Procedures with Important Forms in 15 working days - 999 USD

Important

  • Payment - 60% advance, 40% before document handover.
  • Method of communication - Telephone / Skype / G talk.
  • Language of communication is in English.
  • Documentation using external Cloud server (DROPBOX).

[B] ONSITE IMPLEMENTATION SUPPORT

  1. ONSITE Man day FEES - 350 USD
  2. ONSITE Training & Quality Audit (IQA) FEES - 450 USD
  3. (1 Man day = 7Hrs)
Important
  • Consultants travel across the Globe from Bangalore, India OR Chicago, USA.
  • Payment - 50% before visit and 50% after visit.
  • Travelling & Lodging additional
  • Documentation using external Cloud server.
  • Taxes applicable as per Government rules.

Please Fill the Request For Quote (RFQ) here:
We will send the official proposal with agreement upon receipt of filled RFQ.

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