QUALITY SYSTEM: GENERAL CONCEPT FOR MEDICAL DEVICES MANUFACTURER

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Stana Bekčić

Abstract

Modern medical devicesmanufacturer has to comply with numerous regulations. Depending on a target market, medical devices manufacturer has to fulfils demands of local, national, regional and/or international regulations. Great number of demands must be systematised, and fulfilment has to be planned, organized controlled and followed in a precise and timely manner. Medical devices company should reply to demands of the market imposing ISO standards as control instrument on one side, and on the other, they should reply to the regulations. This paper discusses how the “Sun” Model  can be used for in a company producing medical devices.

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References

[1] ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
[2] Bekčić S, Vidmanić A., Kelečević N., Marinković V., Quality pharmaceutical system: General concept for vaccines manufactures, International Journal of Advanced Quality. 2014.4(42):1-8. Available on: http://www.jusk.rs/Vol.42%20No.4.pdf
[3] https://www.batalas.co.uk/how-to-guides/medical-devices-iso-13485/differences-between-iso-9001-and-iso-13485-explained/
[4] MEDDEV 2. 1/1 April 1994, MEDICAL DEVICES : Guidance document. Available on: https://www.emergobyul.com/sites/default/files/file/europe-medev-2_1-1.pdf