Literature Review on Medical Devices
06 September, 2022 Literature is all of the writings and works written in any branch of science. (Google’s Turkish Dictionary/…
Medical Device QMS
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2017/745 MDR Harmonized Standards
28 April, 2022 What are the 2017/745 MDR Harmonized Standards? In this article, we are going to give you the…
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MDR – Trend Reporting (Article 88)
31 January, 2022 This “Trend Reporting” shall be procedured and planned immediately for transitional substances covered by the MDR. In…
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MDR – UDI Requirements (Annex VI – Part C)
11 November, 2021 MDR – UDI Requirements What is UDI? Unique Device Identifier (UDI) is a series of numeric or…
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Post Market Surveillance – MDR Chapter 7 Vigilance Requirements
02 September, 2021 One of the biggest challenges during MDR transition is to understand what brings new regulation to post…
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MDR – Article 17 – Single-Use Devices and Their Reprocessing
16 July, 2021 With MDR, the reprocessing of single-use devices (MDR Article 17) have also entered our lives. This issue…
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MDR – Article 10 – General Obligations of Manufacturers
08 April, 2021 Whereas old Medical Device Directive has these obligations but new Medical Device Regulation has new ones that…
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MDR Chapter 7 Vigilance Requirements – Reporting of Serious Incidents
10 March, 2021 Nobody wants a medical device that they manufacture to harm a person or result in death. The…
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MDR Article 15 – Person Responsible for Regulatory Compliance
18 January, 2021 If you are not a small company, you might ask yourself: “Shouldn’t we have already a responsible…
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MDR Article 11 – Authorised Representative
18 January, 2021 All “non-EU” medical device manufacturers should have an authorised representative, if they want to sell their products…
