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.

Embolization Coiling: The Importance of Material selection

Embolization coiling is a minimally invasive catheter-based procedure that employs a coil that can cause an occlusion. What’s important is that the design is made easy to handle and produces the desired effect at the intended location.

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.

Optimal Medical Device Prototyping for Getting to Market Sooner

If these core elements are not carefully assessed, planned and tested through prototyping, the problems arising at the FDA approval stage, production stage and usage with the end-users will negate profitability

Biocompatibility Challenges in Structural Heart Device

The biocompatibility of materials used in Structural Heart Devices is of the utmost importance. We explore the challenges presented by each material’s specific functional profile and how it will react when used in a Structural Heart (SH) Device

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.

A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy

Many supply-chain vulnerabilities stem from long lead times and high levels of cyclicity that prevent the maintenance of the right inventory balance. OEM companies must identify and solve supply-chain vulnerabilities and risk exposures by creating effective mitigation and business-continuity plans.

Quasar passes FDA inspection with no 483 findings

Quasar passes FDA inspection with no 483 findings

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Embolization Coiling: The Importance of Material selection

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

Optimal Medical Device Prototyping for Getting to Market Sooner

Biocompatibility Challenges in Structural Heart Device

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

A Second Medical Device Manufacturing Source As a Risk Mitigation Strategy