ISO 13485 certification is a globally recognized standard for quality management systems specific to the medical device industry. It ensures that organizations consistently design, manufacture, and deliver safe and effective medical devices. The certification process involves implementing risk management, regulatory compliance, and thorough documentation practices. Achieving ISO 13485 certification demonstrates a commitment to patient safety, product quality, and regulatory adherence. It enhances credibility with customers, regulators, and stakeholders while supporting market access for medical devices.