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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:

- Document and record controls

- Internal auditing procedures

- Controls for non-conformance

- Corrective and preventative actions

- Process and design controls

- Record retention

- Accountability and traceability


ISO 13485 Benefits :

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

- Access to markets that recognize or require the certification including Canada and Europe.

- Reduce operational costs by highlighting process deficiencies and improving efficiency

- Increase customer satisfaction by consistently delivering quality products and systematically addressing complaints

- Proven commitment to quality through an internationally recognized standard

- Adds transparency to the way complaints, surveillance or product recalls are handled


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.