The Role of Quality Assurance in Medical Device Manufacturing

Medical Device Contract Manufacturing Quality Assurance

The goal of every medical device is to improve the lives of its users. In order to accomplish this, not only does the device need to follow a thorough design schedule, it needs to be rigorously tested to ensure that it is both safe and reliable. In the case of simple devices, there are regulations and international standards that apply, defining what they must adhere to and how they should function. For more complex devices, however, testing quality and compliance with established standards can be a more difficult endeavor.

Thankfully, Keystone Solutions Group is positioned to help you navigate the quality assurance process. Using the latest hardware and software technology, we can perform detailed analyses of your medical devices and ensure that you are delivering a safe and reliable product to your end users. Employing SolidWorks Flow Simulation Premium, PTC Creo Simulate, ANSYS Workbench and more, we leverage every available technology to provide you with the peace of mind that you need before sending your medical product to market.

Not only does this provide you with assurances, it helps to prevent an increasingly common occurrence in the medical industry: medical device recalls. In the last ten years, recalls have increased by over 95%, with the most frequently cited reasons being related to device design, software and nonconforming material or component issues. To combat these, Keystone Solutions Group performs quality assurance tests with a focus on meeting all national and international manufacturing requirements.

At Keystone Solutions Group, we are here to serve you. From the initial product development phase to early design work to final distribution, our team has years of experience taking medical devices to the market. If you’ve been looking for a reliable, trustworthy partner to ensure the quality and safety of your medical device, contact us today to learn how we can help.

Tags: Quality Assurance