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As professionals in the medical device industry, it’s essential to stay up to date with the latest tools, trends, and technologies to keep our clients ahead of the curve. The latest changes we want to bring to the attention of medical device stakeholders’ are the new standards released by the U.S. Food and Drug Administration department.

Implementing the MDR or Medical Device Regulation will bring significant changes to the process of Clinical Evaluation and subsequent post-market compliance requirements. This, of course, is a significant concern for medical device manufacturers in the EU. Some changes may be relatively minor, such as the change in terminology from Essential Requirements to General Safety and Performance Requirements, while others may have a significant impact on the need for clinical evidence and evaluation, leading to modifications in CER processes and collection of additional data from clinical investigations to support a product undergoing review along with an improved quality management system.

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The deadline for EU MDR Audit Readiness has come and gone. Now, medical equipment manufacturers are operating in a new, amplified regulatory environment. The EU MDR

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Are you looking to hire a regulatory consulting company for your medical practice? Find out what you need to know by clicking here. Getting your new medical device to the market

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