Quasar passes FDA inspection with no 483 findings

Quasar passes FDA inspection with no 483 findings

An FDA inspection was conducted at the Quasar manufacturing facility in Shenzhen, October 31  to November 3, 2016.

This is the second consecutive FDA inspection Quasar passed with ZERO findings (no 483). This result endorses Quasar’s commitment to being a world-class medical device manufacturer.

Consistent with Quasar’s legacy of maintaining high quality standards, we focus on quality throughout the facility, whether in employee training, process development, equipment validations and all phases to manufacturing.

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China MAH Policy

China MAH Policy Changes and The massive Opportunity for Medical Device OEMs

The new MAH or Marketing Authorization Holder Policy has opened up a whole new level of opportunities for medical device companies. OEMs must capitalize on the major changes taking place in the Chinese market in allowing high-quality medical devices to be manufactured and marketed without as many restrictions as they experienced prior to the MAH Policy.

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crisis leadership

The Impact of Quasar’s Crisis Leadership Through Covid-19

As rumors of Covid-19 spread in January 2020, and fear gripped most of China, the management had to face facts and realize that a serious crisis was in the offing. Instead of being paralyzed by fear and uncertainty, Quasar’s leadership headed by Ayal Amitai, CEO, began looking ahead, considering courses of action to get the plant working again.

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