Quality Control in Medical Devices - Thematic Intelligence
Summary
Medical devices regulations are ever-changing
The last couple of years has changed the regulatory landscape for medical devices. Regulatory requirements have undergone major changes all over the world, and the ability to navigate these changes is the key to success. Quality control for medical devices includes both a pre-market stage (to obtain regulatory approval) and a post-market stage (to ensure safety and efficacy in a larger test population). Proper navigation of all stages of quality control will continue to be critical to the success of a medical device.
As old regulations are replaced with new ones, and devices are assessed according to new standards, certain medical devices could face barriers in maintaining or gaining market approval.
While the COVID-19 pandemic has changed the medical device landscape in many ways, it has also caused some of the previously mentioned barriers by halting clinical trials and pausing certain medical procedures, which in turn resulted in fewer approvals and also less demand for certain devices.
Scope
Learn how to effectively navigate the market research process to help guide your organization on the journey to success.
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