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.

Medical Device Manufacturing Outsourcing

Outsourcing Medical Device Manufacturing – OEM Top Concerns

Outsourcing the production of your medical device manufacturing can be a big step for your organization. As an Original Equipment Manufacturer (OEM), putting your product in the hands of a Contract Manufacturer (CM) will free up significant time for your design and production teams, streamline the manufacturing process and even give you access to new world markets.

Key Elements of Maintaining a Stable Supply Chain During Covid-19

A supplier’s slow return to operations threatens your ability to deliver – Here is how Quasar successfully maintained a stable supply chain during Covid-19

Advantages Of A Full Service Medical Device Contract Manufacturer

If you’re considering outsourcing your manufacturing process, it’s recommended to look for a partner who can offer end-to-end service. Or a full-service medical device contract manufacturer. Finding the right partner who can help refine your design before diving into production will save big on time and money.

Capatalizing on China’s Rising Medical Device Market

China’s medical device market is enormous. The medical device industry makes up more than $96 billion in healthcare spending, and that number has been growing at a more than 20% pace for several years.

Medical Device Document Control: What To Expect From A Contract Manufacturer

We rely on these best practices for the most efficient change control board process. This ensures that the medical devices we produce are constantly improving and meeting customers’ demands while also continuously meeting existing safety and quality standards.

Return of the Workforce During the COVID-19 Lockdown in China

When the Chinese government allowed manufacturers to re-open in the wake of the COVID-19 lockdown, Quasar and other companies couldn’t simply flip a switch to restart production. One of the biggest challenges manufacturers faced was in finding ways to bring the workforce back to the plant. In Quasar’s case, the majority of our 1,400-person workforce was spread across many different regions of the country.

Quasar passes ISO 13485 Surveillance with no nonconformities

Quasar passes ISO 13485 Surveillance with no nonconformities

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Outsourcing Medical Device Manufacturing – OEM Top Concerns

Key Elements of Maintaining a Stable Supply Chain During Covid-19

Advantages Of A Full Service Medical Device Contract Manufacturer

Capatalizing on China’s Rising Medical Device Market

Medical Device Document Control: What To Expect From A Contract Manufacturer

Return of the Workforce During the COVID-19 Lockdown in China