Quality Standards for Medical Devices

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.

Global trade and health: an Indonesian perspective on the asean medical device directive policy

“…In addition, the most important thing in the competitiveness of this medical device is the fulfillment of ISO 13485 which is certified by LSSMA. ISO 13485 certification is very important to ensure that the medical device industry management system meets the standards [24] . In Indonesia currently there are only two institutions LSSMA and involve auditors from abroad.…”