ISO 13485 Certification

  1. ISO 13485:2003

medical devices quality management system

ISO 13485:2003

Need of ISO 13485:2003 (MDQMS)

The objective of MDQMS i.e. ISO 13485:2003 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2003 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.

Role of ABC

Accurate Business Certification Pvt. Ltd. ( ABC) having the team of Auditor, Lead Auditor and Technical Experts who can conduct a value added Audit and contribute in the continual improvement of your organization.

ABC team can provide the two step audit and you are entitled for the certification of ISO 13485:2003 which is required by your customer or in tender purpose.

WHY ABC ?

There are several Reasons to choose ABC as

  • 1. Value added two step certification process
  • 2. Timely delivery of certificate as committed
  • 3. 24 X 7 support as executive team is always available
  • 4. online processing from Application to certification decision
  • 5. Economical and Competitive Prices of Certification

Benefits Of ISO 13485:2003

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

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thoughts of our

Satisfied customers

ABC delivers well-performing certification, and conduct value-added audits for exploring potential areas of improvement of and leads your business to comply the certified standards. Gradually stacks the satisfied customers.

The conducted audit was comprehensive, and the auditor was easy to get on, His profound assistance was strictly professional. Explained the requirements in depth in most feasible manner. Reports were to the point without missing any breach.
I would recommend them to any company who require any help for standards along with certification and wish them all the best in future.
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Shweta Singh

New Delhi, India
Received ISO:9001 certification for my organization. It helped us to facilitate our QMS and made some excellent internal improvements. ABC’s assistance and expert service throughout the project were commendable. They took the time to understand the organizational structure and our product-oriented services, and boost us to identify where the changes and improvements were required, so that we would work well with industry context.
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Avnish Thakur

New Delhi, India
You’d actually perceived our business and operations very quickly. The gap analysis report was very clear, about what had to be done, for the same thoughtful advice you gave to us. You didn't make it any more complicated than it needed to be. We really appreciated the way you worked with us to make sure we got certification quickly.
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Pawan Khandelwal

New Delhi, India
The environmental management has been well developed and implemented into our system. The simple yet robust documentation structure is apt for the expanse of the company and the type of services which we offered.
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Chandan Chaurasia

New Delhi, India