So how do the quality management system requirements compare? This white paper highlights the strengths and weaknesses of the ISO standard and the FDA regulation, as well as their key differences. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the international market. FDA 21 CFR Part 820 compliance outlines Quality System Regulations for medical device manufacturers and importers. Marketing medical devices at a global level can be a gruelling and onerous task when trying to achieve compliance to various differing regulations.

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