Learning Center

Medical Device Manufacturing Risk Assessment

Assessing Risk: 5 Tips for Medical Device Risk Management

What is Risk Management Risk assessment in medical device manufacturing is an ongoing responsibility and must be managed and perceived as a top priority in the organization. Risk management is a framework used to identify, evaluate, and mitigate risk or potential failures throughout a medical device’s development life cycle. It is an integral part of the process of medical device development and manufacturing, utilized to ensure a medical devices’ effectiveness, reliability, and safety for patients and operators alike. Risk Management Standards for the Medical Device Industry Risk management standards for the medical device industry, are defined by the ISO 14971 quality standard, as [...]

Read more...
medical device design and development

Medical Device Product Development: Make the Process Work for Your Product

Medical Device Product Development: How to Make The Process Work For Your Product The medical device design and development process consists of four main phases from start to finish of a medical device’s product lifecycle: conception, design & development, technology transfer, and mass manufacturing. The following is a simple step-by -step approach on how to make the medical device design and development process work for your product, pertaining to every medical device design and development process phase respectively. These factors are key to quick and successful time to market. Conception From as early as the product conception phase, care should be taken to [...]

Read more...
ISO 13485 Manufacturing

Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process

ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]

Read more...
Design Control Medical Device

A Simplified Introduction to Medical Device Design Control

Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]

Read more...
development of medical device product lifecycle

The Four Phases of Medical Device Product Development Lifecycle

The work that’s required to transition from the conception stage to the mass manufacturing of a medical device product, is as important as it is challenging. Proper management of medical device product development lifecycle can make the difference in bringing medical device products to market quickly and effectively. Here are the four phases you should prepare for when considering manufacturing a medical device product development lifecycle: 1. Conception This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, [...]

Read more...

Quasar’s new top-technology production facility

We are happy to announce the opening of our new manufacturing facility in Dongguan, China. The facility is now in the validation phase and will fully operational for mass production during Q1-2018. The new facility is our newest asset in our effort to deliver higher quality and newer technologies for innovative medical device mass production and process-design services. Share With Colleagues

Read more...

Quasar passes FDA inspection with no 483 findings

An FDA audit was conducted from October 31 to November 3 at the Quasar manufacturing facility in Shenzhen. This is the second consecutive audit Quasar has passed, by the FDA, and the result with NO findings in non-conformance (no 483) endorses Quasar’s renewed commitment to being a qualified medical device manufacturer. Consistent with Quasar’s legacy of maintaining high quality standards, quality is focused on throughout the entire production process, starting from development, and maintained through all phases to manufacturing.

Read more...

quasar launches new BRANDING

Quasar is pleased to launch its official new BRAND, revealing the company’s strategic change in direction to reflect its focus on the medical device market. Our NEW BRANDING

Read more...

NPD | New Product Development

Manufacturing excellence begins in the planning stages, even before production commences. The company initiates the first phase, new product development (NPD) process in complete coordination with the customer.

Read more...
ISO 13485 Manufacturing

Why ISO 13485 Might Not Be Enough for Your Medical Device Manufacturing Process

ISO 13485 manufacturing is an established quality standard, pertaining to medical device manufacturers. However, as with any quality standard, it is more a set of general guidelines which every manufacturer applies to their own situation according to their status, infrastructure, and working conditions, rather than a recipe for success. There are multiple ways in which it can be applied to each manufacturer’s case, therefore making each medical device manufacturer responsible for guaranteeing their operational effectiveness and success, independent of their ISO 13485 manufacturing certification. An Overview Of ISO 13485 Manufacturing Quality Standard First published in 1996, ISO 13485 in manufacturing is [...]

Read more...
Design Control Medical Device

A Simplified Introduction to Medical Device Design Control

Often, when working on developing a medical device and its design control, designers and engineers find themselves stuck or having to repeat the same processes, again and again, to fix and perfect their design. Considering these seven common steps for design and control of medical devices can help a team avoid some of the most common pitfalls. Since 1990 and 1993, the US (21 CFR 820.30) and EU (MDD 93/42/EEC) respectively included Medical Devices in their GMP (Good Manufacturing Practices) set of rules and regulations, with the International Standards Organization (ISO) following suit in 1996 by publishing their voluntary ISO [...]

Read more...
development of medical device product lifecycle

The Four Phases of Medical Device Product Development Lifecycle

The work that’s required to transition from the conception stage to the mass manufacturing of a medical device product, is as important as it is challenging. Proper management of medical device product development lifecycle can make the difference in bringing medical device products to market quickly and effectively. Here are the four phases you should prepare for when considering manufacturing a medical device product development lifecycle: 1. Conception This phase contains several steps from idea conception, the use context of the medical device, initial concept development, up to proof of concept. These ideation processes generate abstract concepts in need of further development, [...]

Read more...

The Secret Sauce to high quality

The Secret Sauce to high quality: Preventative Quality Processes and Sisyphean Improvement Cycles. Preventive quality processes and Sisyphean Improvement Cycles are the secret sauce to winning your market. Do you have them built into your production process?

Read more...