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Research Article Open access CC BY 4.0

Enhancing Safety and Compliance in Syringe Manufacturing: A Study of Risk Management Strategies Based on ISO 14971

Akash Sharma, Chandra Prakash, Ankur Vora

Journal of Advances in Medical and Pharmaceutical Sciences · pp. 57–78 · Published 3 Aug 2024

10.9734/jamps/2024/v26i7702

Abstract

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.

Syringe manufacturing risk management safety compliance

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Cited by 1

Comparative Review on E-Beam and Gamma Radiation Sterilization Methods: Effectiveness, Safety, and Cost Considerations

Akash Sharma, Chandra Prakash, Ankur Vora · Microbiology Research Journal International · 2024

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