ADVANTAGES OF MANUFACTURING ACCORDING TO INTERNATIONAL STANDARDS

O.E Jiyanbayev; I.N. Abdullayev

Authors

Jiyanbayev O.E Center for the development of professional qualification of medical workers
Abdullayev I.N. Center for the development of professional qualification of medical workers

Abstract

Manufacturing medical devices according to international standards offers numerous advantages that extend beyond mere product quality improvement. One of the primary benefits is the enhancement of product quality itself, as standards like ISO 13485 establish rigorous process management and documentation protocols, ensuring consistent quality through continuous monitoring and efficient resource utilization. This not only builds consumer trust but also bolsters the brand's reputation.

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References

1. ISO 13485: Medical Devices u2013 Quality Management Systems u2013 International Organization for Standardization, 2022.

2. IEC 60601: Medical Electrical Equipment u2013 General Requirements for Basic Safety and Essential Performance u2013 International Electrotechnical Commission, 2021.

3. ISO 14971: Application of Risk Management to Medical Devices u2013 International Organization for Standardization, 2020.

4. FDA Regulatory Requirements for Medical Devices u2013 US Food and Drug Administration, 2022.