Quasar passes ISO 13485 Surveillance with no nonconformities

Quasar passes ISO 13485 Surveillance with no nonconformities

In Dec 2016, BSI Auditors pored over DHRs, validations and quality objectives; then toured the lines and reviewed procedures during Quasar’s annual audit. We are happy to announce that Quasar was found ISO 13485 compliant, surpassing requirements in every category.

Following the zero 483 findings of the Nov 2016 FDA Inspection, this is yet another confirmation of the strength of our management and quality systems, reaffirming better outcomes for our customers and their patients.

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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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