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By Hilde Viroux and Maggie Chan (PA Consulting) and Dona O’Neil (Northeastern University) | This article dispels the myth that obtaining EU MDR certification is an end point. The evolving landscape demands ongoing diligence to comprehend and adhere to changing requirements. |
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By Philip Howie, Ph.D., Springboard | Despite the best intentions of procurement, suppliers may impose changes in the availability of material grades. Have a process for controlling and mitigating the effects of material changes in order to reduce risk and avoid interruption. |
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By Erika Roberts, ELR Lab Services LLC | The proposed FDA regulation for laboratory developed tests marks a significant step toward the FDA trying to standardize oversight for these diagnostic tools. As the FDA seeks public input, stakeholders grapple with the implications of increased regulatory scrutiny, debating its impact on patient access, innovation, and the overall landscape of diagnostic testing in the U.S. |
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| Manufacturing Transfers For Medtech OEMs: Part 1 | White Paper | Flexan | Quality management is a mission-critical function of all MedTech manufacturers. Attention to quality issues when selecting vendors and partners can help manufacturers prevent downstream issues. |
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| Back To Basics: Breaking Down The Fundamentals Of Filters | Article | Knowles Precision Devices DLI | Regardless of the technology behind the filter, there are several key concepts that all filters share. Explore fundamental filter information that will help simplify future filtering decisions. |
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