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.

Post-Market Surveillance for a Medical Device: What You Need to Know

In addition to the regulatory requirement, post-market surveillance offers an opportunity for collecting market data that can provide valuable insight into the device improvement. In this article, we cover some of the tremendous value that can be created both on the business side and the engineering side when post-market surveillance is done correctly for your medical device.

How to Create an Efficient Change Control Board Process

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.

COVID-19 Case Study: A Demonstration of Resilience and Operational Excellence

How Quasar was able to ensure the safe return of over 1,300 employees with zero cases of infection found and resumed operations in just 3 weeks.

Considerations for Setting a Process Validation for Your Medical Device

The FDA and other health authorities require for every medical device to meet production standards. Process validation is crucial for meeting these standards and bringing your new medical device to market.

5 Considerations When Selecting Medical Device Materials for Your Product

Material selection for your medical device is so important. If done wrong it can hurt your business, but if done right, it can aid in your product’s commercial success. Depending on your medical device, the task of selecting the right materials can be as simple as it can be daunting. Moreover, your material selection directly ties in to major design choices that you will take, based on those material’s attributes.

How to Determine the Critical Testing Methods for a Medical Device

Testing is a crucial part of the manufacturing process which ensures your medical product delivers top results. In today’s world health crisis and economic disarray, quality and precision of your medical products need to be a top priority. Because in medical device manufacturing, there is simply no room for shortcuts.

Quasar passes FDA inspection with no 483 findings

Quasar passes FDA inspection with no 483 findings

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Post-Market Surveillance for a Medical Device: What You Need to Know

How to Create an Efficient Change Control Board Process

COVID-19 Case Study: A Demonstration of Resilience and Operational Excellence

Considerations for Setting a Process Validation for Your Medical Device

5 Considerations When Selecting Medical Device Materials for Your Product

How to Determine the Critical Testing Methods for a Medical Device