In:
International Journal of Drug Regulatory Affairs, Society of Pharmaceutical Tecnocrats, Vol. 2, No. 4 ( 2018-02-13), p. 19-24
Abstract:
Formerly with more augmented disabilities, Medical devices have become decisive device in many circumstances. As these are more perilous, the manufacturer should endow with an ideal medical device in aspects of safety & quality. To produce a homogeneous device globally, there should be some standards to be followed within an explicit country and standard throughout the globe, complying with the quality. In milieu of this resemblance of device globally, International Organization for Standard (ISO) has issued a standard, ISO 13485. This article is made to furnish the details about ISO 13485 and the Quality management system followed by United States manufacturer’s to market their devices within the country, i.e., 21 CFR Part 820.
Type of Medium:
Online Resource
ISSN:
2321-6794
,
2321-7162
DOI:
10.22270/ijdra.v2i4.149
Language:
Unknown
Publisher:
Society of Pharmaceutical Tecnocrats
Publication Date:
2018
detail.hit.zdb_id:
2738279-5
SSG:
15,3
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