ISO 13485





ISO 13485 Certification play a crucial role, if you are a medical device manufacturer or trader or designer. They not only help build trust but have become a mandatory requirement for CE Marking as per MDD, IVD or AIMD Directive.

QARA provides Guidance and training online for successfully Implementing ISO 13485 quality management system and followed by certification.

QARA expert assistance online is very economical and fast. Organizations interested to work with us can appoint one dedicated person to interact with consultant by telephone/Skype/G talk & Email.


THE NEW, SIMPLE WAY TO GET ISO 13485 CERTIFIED

QARA long distance, Cloud and Video conferencing based online consultancy for ISO 13485 guidance, documentation and auditing.

QARA allows you to save both precious time, money and output.

No matter where you are OR where we are....

Contact us to get started.





 

What we do for you?

  • Understanding your activities and planning for Certification
  • Identify the necessary procedures
  • Consultant will provide draft procedures and formats
  • Will provide Draft Quality Manual
  • Awareness Training
  • Internal auditing
  • Internal audit
  • Support during External audit
  • Support for closing the non conformities

How to achieve ISO 13485 Certificate?

  • GAP Analysis
  • Fill the GAPS by preparing necessary documents
  • Implement procedures
  • Calibration and validation wherever necessary
  • Understanding your activities and planning for Certification
  • Identify certification body
  • Invite for Certification
  • Audit

ISO 13485 Documentation support Fees

  • Supply of necessary procedures after understanding your business and process – 849 USD ( 14 Days)
  • Supply of Quality Manual after Understanding of your business and process – 549 USD ( 7 Days)
  • Supply of relevant Forms to support procedures - 449 USD ( 7 Days)
  • Awareness Training for 8-10 members - 249 USD ( 7 Hrs.)
  • Internal Auditor Training for 8-10 members - 349 USD ( 7 Hrs.)
  • Verification of Procedures and Quality Manual - 349 USD ( 5 Days)
  • Internal Audit - 249 USD ( 1 Day)
  • Calibration and Validation guidance - 249 USD / 4 Hrs
  • DHR Guidance and Format – 1000 USD ( 14 Days)
  • Risk Analysis Check List – 249 USD ( 3 Days)
  • ISO 62304 Implementation - 1500 USD ( 7 Days)

Payments

All payments to be made to I 3 Consulting as per the details mentioned in invoice.

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