ISO 13485 is an international standard for quality management systems specific to the medical device industry. It provides a framework for organizations to design, develop, manufacture, and deliver safe and effective medical devices while ensuring regulatory compliance. The standard focuses on risk management, product consistency, and continuous improvement throughout the product lifecycle. Achieving ISO 13485 certification demonstrates a commitment to high-quality medical device production, patient safety, and meeting the strict regulatory requirements that are essential for market access and customer trust in the healthcare sector.
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