ISO 13485 

The ISO 13485 standard is a Medical Device quality management system that demonstrates the ability to provide medical devices and its related services to meet the consumer needs. The regulatory requirement of ISO 13485 clauses is applicable only on medical devices and its related services.

The benefits of implementing ISO 13485:
The medical manufacturers who seeking access to the new market and those who want to effectively compete should properly implement ISO 13485 standard. It opens doors for both domestic and international market. Discover how it can transform your products and deliver them to the market.

Some benefits of implementation ISO 13485 Certifications
  ->  Investing and implementing such system speeds up your market access and builds your recognition globally. 
  ->  Implementation, reduce your cost of the sales and enhance the company’s creditability.
  ->  It improves your performance and fosters the strong relationship with your suppliers, customers and business partners.

How do you start to implement ISO 13485? What is involved?

The ISO 13485 standard focuses to provide medical device management system. It adds value, remove waste, improved connectivity and ensure system’s functionality.
  ->  Appoint a management representative that ensures meeting customer and regulatory requirements.
  ->  Understand how you get better and find ways to increase efficiency and cost saving through ISO 13485 certifications.
  ->  Monitor your supply chain, train and motivate your staffs to make your system quality management friendly.
  ->  Follow basic principles of ISO 13485 standards. 

Why seek certification to ISO 13485?
Globally recognized ISO 13485 certification shows commitment to quality medical products and a positive willingness to work towards improving efficiency.

Moreover, it addresses the additional safety and regulatory specific to the medical industry. This is an ultimate way to enhance the company’s image in the international market and make customer, stakeholders and employees to trust upon the company.

Furthermore, it eliminates the need of multiple certifications. The certification reduces waste, create creditability, strengthen market access and develop trust factor. It satisfies the rigours of an independent external audit and this quality concern specifies your medical devices industry.

Why to choose AGQR certification for your audit? 

American Global Quality Registrar is an accredited certification body. We provide certification against a variety of management systems including ISO 13485 certification medical devices.

While quality has been our first priority and now we have come with the more systematic approach to help your business keep ahead in the competition.

ISO 13485 Audit Process:
Now, external audit is needed to review the quality manuals and procedures in almost every region of the medical mechanism. You need a third party or any control system that assures the quality of the working system in the entity, and AGQR will successfully do it for you. The process has been designed to evaluate the quality and the targets are measurable and ascertainable.
After the successful audit, ISO 13485 certification will be issued.  

What is the cost of audit ISO 13485?

It costs to less to adopt the audit mechanism through ISO 13485 clauses in the medical field because the ISO 13485 standards are easy to comply with the requirements. Whatever it costs, it can ultimately recover the same by assuring the less error in the entity and by utilising the resources at its optimum level.

Where to obtain further information or help

For more information about our reliable support towards ISO 13485 certifications, you can contact our consulting offices, visit our web portal and e-mail us



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