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ISO 13485

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ISO 13485

>What Is ISO 13485?

ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2003, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.


ISO 13485 requirements :

In order to achieve ISO 13485 certification, you must develop written policies for the following functions:


ISO 13485 Benefits

Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification:


Our Role :

With credo & confidence, we are specialized in Consultancy of High Quality Process of ISO 13485 based on International Standards. Trained manpower is our dedicated strength.

We have carried out different Certification through our internationally recognized reputed Certification bodies.

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ISO 13485

ISO 13485

Quality Management System specifically tailored for the Medical Devices.

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