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.

Clinical Trials Reporting Requirements in EU Countries

By |January 9th, 2024|Categories: EU MDR, Latest Publications|

Clinical trials are important. The discovery of any new medical treatments is a standard step for testing the device on human subjects in a safe, controlled environment where the results and process can be [...]

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Quality Management System: What ISO Standards Say About QMS

By |December 26th, 2023|Categories: EU MDR, Miscellaneous|

A quality management system is a huge part of producing medical devices. Whether you like the process or not, a well-designed and well-executed QMS is your security man who controls what goes in and [...]

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Fundamentals of a Literature Review: A Beginner’s Guide

By |December 19th, 2023|Categories: EU MDR, Literature Search and Literature Review|

The medical device industry is fueled by innovation. Research and development are the blood that keeps it going. Each day, we advance a little more to better human health. Thousands of people worldwide work [...]

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Medical Device Development: When Should you do Clinical Evaluation?

By |December 12th, 2023|Categories: Clinical Evaluation Reports - CER, EU MDR, Miscellaneous|

The medical device development process is not a one-step operation. Instead, it is a multi-phase process requiring meticulous planning and implementation so that you get a safe and effective device at the end of [...]

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How Risk Management and Post-Market Surveillance Interact with Clinical Evaluation

By |December 5th, 2023|Categories: Clinical Evaluation Reports - CER, Post Market Surveillance|

Developing a medical device is not a one-step process. There are hundreds of little steps, from drawing the design to finalizing it to actually creating the device. Between all these steps, there is always [...]

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