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ISO 13485
Management System
For organizations involved in the design, production, installation and servicing of medical devices and related services.
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Most accepted global standard for medical device industry.
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Easy integration with other ISO management systems
​How will it help you?
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International standard for assuring quality management system specific to medical device industry.
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ISO 13485 certification will ensure your devices and services are safe, effective, and delivered to high standards.
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Through this standard, you can showcase your competency in running smooth and safe operations.
How can we help you?
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We provide expertise in attaining and maintaining ISO 13485.
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We will walk you through how ISO 13485 will improve and validate your business operations.
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We will start by assessing your business, then help you to use the results to improve your medical device manufacturing QMS.
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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.
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We will ensure you have successful ISO 13485 certification that will provide safety assurance to your employees and credibility to your business.