Ensuring the safety and compliance of syringes is crucial in the medical device industry to mitigate risks and uphold quality standards. This research paper examines effective risk management strategies for syringe manufacturers, grounded in the principles outlined in ISO 14971. The ISO 14971 standard provides a systematic framework for identifying, evaluating, and controlling risks throughout the product lifecycle. By integrating these strategies into manufacturing processes, syringe manufacturers can enhance product safety, achieve regulatory compliance, and improve overall quality. This study synthesizes current practices and case studies to illustrate the practical application of ISO 14971 in enhancing safety and compliance within the syringe manufacturing industry.
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Sharma et al. (2024) studied this question.
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