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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Medical device manufacturing

Common Mistakes when Transferring Medical Device Manufacturing to High Volume

In the following article we cover some of the common mistakes that are made when transferring medical device manufacturing to high volume. The ability to identify these areas at an early stage together with proper management, can be critical to a medical device’s lifecycle. These common pitfalls that result in costly corrective actions can be avoided altogether.

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Case Study: Plastic Molding DFM

Introduction It’s not uncommon for companies to seek a device manufacturer after having completed the prototype development phase. That’s because they mistakenly assume that the product development team has manufacturability in mind. On the contrary however, experience shows that during development, engineers will focus on design outputs to meet the design inputs. And not enough focus goes into product manufacturability as is necessary. It is absolutely critical to involve the device manufacturer from early on in the design phase. Otherwise, companies run the risk of developing products that will have issues with manufacturability that pose serious challenges in later stages. This study [...]

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