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.

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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