Publications

Publications2022-10-27T22:32:34+00:00

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Latest Publications

Look here for Industry updates and technical tutorials written by the CiteMed staff.  All things Medical Device Regulation are covered in our publications.

The DIY Clinical Evaluation Report – Do You Really Need A CER Writer?

By |April 17th, 2024|Categories: Clinical Evaluation Reports - CER, EU MDR|

So you’ve taken a look at EU MDR transitions for some of your devices and shopped around for quotes on help writing the technical file. One of the more common tasks is taking a look [...]

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Navigating Global Medical Device Regulations

By |February 20th, 2024|Categories: EU MDR, Latest Publications, Literature Search and Literature Review|

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex. Navigating through these regulations requires a deep understanding of the nuances that [...]

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Navigating Medical Device Safety, Regulation, and Adverse Europe

By |February 13th, 2024|Categories: EU MDR|

Adverse Events in Europe The landscape of medical device safety in Europe is significantly influenced by the occurrence and management of adverse events. An adverse event in this context refers to any untoward medical [...]

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Medical Device Regulations – Links You Should Be Aware Of

By |January 29th, 2024|Categories: EU MDR, Latest Publications|

Medical device regulations are no joke. It's pretty important to get the regulations right, since even a single missed data, if significant enough, can result in years of delay in getting a CE mark. [...]

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Before You Hire a Clinical Evaluation Consultant: Read This

By |January 23rd, 2024|Categories: Clinical Evaluation Reports - CER, EU MDR, Latest Publications|

Thinking of Hiring a Clinical Evaluation Consultant? So it's finally time to either start that new Clinical Evaluation Report (CER) project for Europe, or remediate your current documents based on Notified Body feedback... and [...]

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Unexpected Documents You Might Need for Your Clinical Evaluation Report

By |January 16th, 2024|Categories: Clinical Evaluation Reports - CER, Latest Publications|

Medical device regulation is important. Not just because we work with them. But because they control and regulate devices that diagnose, treat, and monitor literally all health disorders. And for this very reason, no [...]

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