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FDA compliance for medical device

Image result for 21 CFR 820

THE BEST AND SIMPLE WAY TO GET YOUR ORGANIZATION SUCCESSFULLY COMPLETES FDA 21 CFR 820 (GMP) AUDIT.

United Sates Food and Drug Administration instructs certain type of medical device manu facturer to develop a Quality Management System (QMS) commensurate with:

  • Risk presented by the device.
  • Complexity of device and manufacturing processes.
  • Size and complexity of organization.

Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, Designers and initial distributors of foreign entities performing these functions Quality Workforce and its team can assist you both through ONLINE and ONSITE consultancy It is Fast, Economic and convenient to employees in charge of Implementing GMP in the organization. No matter where you are OR where we are....Contact us to get started.

What we do for you?

  • Understanding your activities and Prepare the Implementation program with time schedule.
  • Identify the necessary procedures
  • Supply of draft procedures and formats
  • Supply of Draft Quality Manual
  • Awareness Training
  • Internal auditing
  • Quality audit
  • GAP Analysis

21 CFR 820 - Quality Workforce Documentation and Training Fee.

SL.NO ACTIVITY FEE TENURE
01 Draft and provide necessary procedures after understanding your $ 1600 14
business and process based on the scope of 21 CFR 820
 $ 1600  14 Days
02  Draft and provide Quality Manual after Understanding of your
 scope of 21 CFR 820
 $ 650  7 Days
03  Supply of relevant Forms to support procedures  $ 600  7 Days
04  Awareness Training for 8 -10 members  $ 800  7 Hrs
05  Internal Auditor Training for 8-10 members  $ 1500
 7 Hrs
06  Verification of Procedures and Quality Manual  $ 600
 5 Days
07  DHR Guidance and Format  $ 1000  14 Days
08  Risk Analysis Check List  $ 650  3 Days
09  Pre – FDA Inspection Preparation ( Those clients received
 inspection notices from FDA )

 $ 3000+Travelling+lodging

 2 Days
10  Closing of NC’s (Post – FDA Inspection)  $ 1400  1 Day

Contact us