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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Quasar passes FDA inspection with no 483 findings

An FDA audit was conducted from October 31 to November 3 at the Quasar manufacturing facility in Shenzhen. This is the second consecutive audit Quasar has passed, by the FDA, and the result with NO findings in non-conformance (no 483) endorses Quasar's renewed commitment to being a qualified medical device manufacturer. Consistent with Quasar's legacy of maintaining high quality standards, quality is focused on throughout the entire production process, starting from development, and maintained through all phases to manufacturing.

quasar launches new BRANDING

Quasar is pleased to launch its official new BRAND, revealing the company's strategic change in direction to reflect its focus on the medical device market. Our NEW BRANDING