ISO Standards of Medical Devices

  • Dharavath Deepika Department of Pharmaceutical Regulatory Affairs, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, A.P., India
    rampharma83@gmail.com
  • Ramaiah Maddi Department of Pharmaceutical Regulatory Affairs, Hindu College of Pharmacy, Amaravathi Road, Guntur-522002, A.P., India https://orcid.org/0000-0002-9597-3467

Abstract

The medical device has become a decisive device in many instances. As there are more unsafe, the producer should bestow with an ideal medical device in phases of quality & safety. To produce a consistent device universally, there are some standards to be followed. Standards can cover a broad range of business and technology types, including IVDs and medical devices, and software that escort them. Standards are essential to maintain product compliance while synchronizing comparable requirements both nationally and internationally. For medical device industrialists, ISO standards derogatory not only making high-quality medical devices but enduring amenable to regulatory requirements while doing. For medical device companies, adherence to ISO medical device standards can lead to the elaboration of safer and more efficacious products that are more closely allied with user needs. In addition, attaining ISO correspondence certification is a required step in retrieving certain international marketplaces.

Keywords: Medical Device, ISO Standards

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Published
13-05-2022
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114 Views | 74 Downloads
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How to Cite
Dharavath, D., and R. Maddi. “ISO Standards of Medical Devices”. World Journal of Current Medical and Pharmaceutical Research, Vol. 4, no. 3, May 2022, pp. 33-39, doi:10.37022/wjcmpr.v4i3.213.
Section
Review Articles