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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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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