Q. What is ISO 13485 certification, and why is it important for medical device companies?
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What is ISO 13485 certification, and why is it important for medical device companies?

ISO 13485 certification is an international standard specific to the medical device industry. It establishes requirements for a quality management system that ensures the design, development, production, and distribution of safe and effective medical devices. ISO 13485 certification is crucial for medical device companies as it demonstrates compliance with regulatory requirements and enhances the credibility of their products. It assures customers, regulatory authorities, and business partners that the company has implemented robust quality management systems, resulting in safer and more reliable medical devices.


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Jul, 2023

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