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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EU MDR 2020: What to Expect

The EU MDR allowed a 3-year transition period for medical device manufacturers to comply. This runway ends in May 2020, where after the EU MDR comes into full effect. After this point, every part of the medical device supply chain from manufacturers to importers and distributors in the EU, will be required to comply.

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