Literature Review on Medical Devices

Literature is all of the writings and works written in any branch of science. (Google’s Turkish Dictionary/ Oxford Languages ​​) For medical device manufacturers, PSUR / PMS ( ) are the resources we frequently refer to in our studies. In this article, especially experienced people who are new to the profession or who are just familiar with the medical device will find short tips for literature review on medical devices.

What is a literature review study and how is it done?

Literature review is one of the first steps to be taken not only in academic studies but also in every innovative field. (Köroğlu, S.A. ‘NOTES ON LITERATURE REVIEW AND A REVIEW TECHNIQUE’ Year 2015, Issue 1). Gash defined this process as the in-depth and systematic search and identification of as many published works on a particular subject as possible. (1)

Before you start to search for resources, it will be useful for you to learn what keywords are determined and assigned by your company for your device, in order to use your time effectively. If you type the relevant words in the search section of the sites that allow resource browsing, and then filter the results according to the date range you specify, you will see the literature studies related to your device in order.

How can you understand the relevance without reading all of the listed literature studies?

*The application area, which is written in the information summary of the study, can be checked first. (For example, orthopedics, neurosurgery)

*If the application area is different, the study can be eliminated directly.

*If the application area is suitable, the role of the medical device in the study can be checked. (Is it used as a main product or an auxiliary product?)

*Which features of the medical device were focused on in the study

*Is this focus functionally appropriate in current use? (For example: If the hand tool used in the study is larger than the place of use in the human body, the study may be eliminated if it is decided that it cannot be applied in a functional sense.)

*If the medical device in the study is applicable to an equivalent device and functionally up-to-date product, can it be re-evaluated in the field of risk analysis, customer satisfaction improvement or performance field? These inquiries can be made.

Facilitator Hint for Literature Review on Medical Devices

The high use of Latin words while examining the literature can sometimes be a challenge for Quality or R&D engineers to understand and match words. In cases where the translation doesn’t work, the most common method we use as ACF is to Google the Latin word and review the images. Scanning of images can give quick answer about the application area. No matter how many foreign words are, the process of examining the studies starts to become easier for the employee after an average of 5-6 literature reviews.

In other words, you do not need to have a medical education to be able to search the literature on medical devices that are the input of PSUR / PMS studies.

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  2. Regulation (EU) 2017/745/Annex III. Technical documentation on post-market surveillance

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