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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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Are you wondering how you can choose between the top consulting companies for medical devices? Read on and learn more here. Medical device companies don't often have al

The FDA medical device approval process has changed several times over the years. We take a look at how these processes work now. In 2020, there were 40 medical devices passed by the

From the global semiconductor shortage to the uptake of artificial intelligence, we look at the medical device industry trends to watch. In the last few decades, everybody has experienced rapid advancements and revolutions in

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

Are you in the market for a medical devices consultant? Read here for nine practical tips for choosing the right medical devices consultant for your needs. Any scientific professional knows

Are you swamped with medical writing projects? Click here for nine amazing reasons that you should start outsourcing your medical writing projects. Are you finding all your effort

Are you interested in learning more about the role of a medical devices consultant? Read more about medical devices consulting here. You've got an amazing medical device ready to

Do you manufacture or use medical devices sold in the European Union (EU) market? If so, are you in compliance with the EU Medical Devices Regulation (EU MDR)? The COVID-19

What are the current regulatory standards for medical equipment? This is a guide to the latest medical regulations and the transition to EUMDR. The European Union has the second-largest medical device market after the US. Yo

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

Have you been directed to a medical device consultant? Discover all you need to know about medical device consultants and make sure you get the best care today! There were 1,044,706 active physicians in the U.S. in

The medical device industry depends on regulatory affairs professionals - but what do they do? Learn more about medical device regulatory affairs specialists. medical device regulatory affairs

Are you considering hiring a medical device consulting service? Discover all you need to know and how to choose the best services for your company. Consulting services