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ISO 13485 
Management System

For organizations involved in the design, production, installation and servicing of medical devices and related services.

Most accepted global standard for medical device industry. 

Easy integration with other ISO management systems

​How will it help you?

  • International standard for assuring quality management system specific to medical device industry. 

  • ISO 13485 certification will ensure your devices and services are safe, effective, and delivered to high standards. 

  • Through this standard, you can showcase your competency in running smooth and safe operations. 

How can we help you?

  • We provide expertise in attaining and maintaining ISO 13485. 

  • We will walk you through how ISO 13485 will improve and validate your business operations. 

  • We will start by assessing your business, then help you to use the results to improve your medical device manufacturing QMS.

  • We work with the senior management team to ensure the ISO 13485 standard framework is embedded throughout your organization before you are assessed by a third-party auditor who awards the certification. 

  • We will ensure you have successful ISO 13485 certification that will provide safety assurance to your employees and credibility to your business.

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