ISO 13485:2016 

By becoming certified in the ISO 13485 standard your company will:

  1. Increase the probability of making safe and effective medical devices
  2. Meet regulatory requirements
  3. Meet customer expectations
  4. Help monitor the effectiveness of your supply chain
  1. This standard is recognized by most major markets around the world (United States of America, Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard.  With ISO 13485 certification you will be able to enter any major market around the world with one audit!
    By becoming ISO 13485 certified your company’s Quality Management System (QMS) will be in line with the Food and Drug Administration’s (FDA) QSR standards.    

Additional Benefits of ISO 13485 certification:

  1. Increased Efficiency
  2. Cost Savings
  3. More Effective Risk Management and Quality Assurance
  4. Improved ability to respond to Customer Requirements

ISO 13486:2016 Services

ISO 13485 is the internationally recognized standard for quality management systems in the medical device industry. It is designed and intended for use by organizations for the design and development, production, installation, servicing and sales of medical devices. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices, and that related services consistently meet customer requirements and applicable regulatory requirements.

Benefits of ISO 13485:2016 Certification:

  • Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements.

  • Reduced operating costs – through continual improvement of processes and resulting operational efficiencies.

  • Improved stakeholder relationships – including staff, customers and suppliers.

  • Improved risk management – through greater consistency and trace-ability of products and use of risk management techniques.

  • Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers.

  • Proven business credentials – through independent verification against recognized standards.

  • Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.

SERVICE INFO

QUALITY 100%
PRICING 60%
TIMELY PROCESSING 99%

NORMAL HOURS

Week Days 8:00 – 5:00
Saturday 9:00 – 5:00
Sunday 11:00 – 4:00

  +91-9015631570

  +91-9555131570

LOCATION

NEW DELHI

QUALITY GUARANTEE

Increase access to more markets worldwide with certification Outline how to review and improve processes across your organization. Increase efficiency, cut costs and monitor supply chain performance. Demonstrate that you produce safer and more effective medical devices. Meet regulatory requirements and customer expectations.

FREE QUOTE

Do you need help to earn certificate for your company? Fill out this form to get in touch.

      LOCATION

      NEW DELHI

      WORK PROFILE

      CERTIFICATION SERVICES

      WORKING HOURS

      9:00am – 6:00pm

      LOCATION

      NEW DELHI

      WORK PROFILE

      CERTIFICATION SERVICES

      WORKING HOURS

      9:00am – 6:00pm