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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post-market surveillance medical device

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.

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change control

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.

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medical device materials

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.

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Medical device testing

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.

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