ISO 13485

ISO 13486 certification

What is ISO 13485?

ISO 13485 Quality Management System for Medical Devices. For medical manufacturer seeking new market entry Opportunities, conformity with regulatory requirement is most often a prerequisite. Those who want to complete effectively should also have in place a properly implemented & maintained Quality Management System. To satisfied these QMS needs, Many manufactures are discovering with green dot. With our Expertise Experience and know? how, we are your business coach for implementing ISO 13485. ISO 13485 provides a harmonized standard Set of Quality Management System requirement for medical device manufactures. Based on process approach to Quality Management System, It focuses on what a manufacture does need to provide to safe & effective medical device. If you find implementing CE ISO 13485 certification is difficult, Start Implementing ISO 13485 which will help you to get CE for your product easily

Benefit Of ISO 13485 ( Quality Management System Requirement for Medical Devices)

Few Benefit of implementation ISO 13485 are as given below:

  • It is a globally accepted standard for a quality management system that can be applied to any company of organization deals with the medical devices industry.
  • IS013485 provides worldwide recognition for United States manufacturers in compliance with the FDA quality system regulations.
  • The companies or organization that implements an ISO 13485 quality system are taking a step forward to execute business in a highly regulated industry.
  • The companies or organizations can easily show a serious commitment to quality for the medical devices to their client and customers.
  • It allows a company or organization to be more cost effective.
  • It enhances product safety and quality and provides a base to meet regulatory requirements.
  • A company can gain a potential doorway into global markets.
  • The ISO 13485 certification can create a structure for implementing a methodical approach to check or monitor the organization?s quality processes and customer?s feedbacks
  • ISO 13485 is best solution for securing and sustaining a global business.

How we are different for ISO 13485 ?

  • Implementing Experience for Medical devices of class 3A, 3 b
  • Result oriented process improvement base consultation
  • Time bound completion of project
  • Risk base audit and Assessment
  • Qualified team to help you
  • practical implementation with training
  • Expertise of almost 15 years
  • Cost effective
  • Approved Consultant in NPC ( National Productivity Council )
  • Help you get subsidy too.
how can we help you?

Contact us at the office nearest to you or submitted business inquiry online.

Nirav Trivedi, you presentation & thoughtful technique are very easy to understand very effective Management Consultant.

Dharmesh Mistry
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