What does ISO 13485 certification mean?

How important is it to medical device manufacturing, trading and maintenance services? and why is it required by SFDA in Saudi Arabia ?
How can it help your organization?

Eng.Musaed will provide some answers to these common questions throughout this thread, but let’s start from the beginning as below…

For ISO13485 / ISO9001 / ISO14001 / ISO45001 and many other standards qualification and certification inquiries, please use below form:


Within the ISO13485 standard sections and clauses exist that address the aspects of design, development, production, operations, inspection, testing, packaging, labeling, installation, servicing, repair, maintenance, disposal, and documentation of medical devices. The purpose of the ISO_13485 standard is to help manufacturers & traders produce & maintain safe, reliable, and effective medical_devices to their clients.

– By following the guidelines in this standard, manufacturers & traders or services providers can:

• Ensure products are manufactured according to industry-accepted best practices.
• Reduce the risk of product recalls due to defects or malfunctioning parts.
• Avoid costly lawsuits from patients injured by defective products.
• Improve patient outcomes.
• Increase customer satisfaction.
• Meet government regulations.
• Maintain a good corporate image.
• Achieve faster fycle times, less waste, systematic process improvement, higher chances to win tenders or export orders.

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