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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oem audit

How to Conduct an OEM Audit for a Medical Contract Manufacturer

Conducting a medical device manufacturer audit, includes a multitude of items to examine. Especially when considering the gamut of OEM activities: from simpler manufacturing operations, to vertical production facilities. In this article we cover the most important items to consider, as well as some additional factors that demonstrate above average OEM operations.

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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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