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.

6 Clinical Evaluation Report Mistakes and How to Avoid Them

By |April 4th, 2023|Categories: Clinical Evaluation Reports - CER|

The clinical evaluation report (CER) is crucial for medical device approval in most countries. It is a comprehensive report summarising the device's safety, performance, and effectiveness based on clinical data. The CER plays a vital [...]

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CER Checklist: 12 Attributes of an Excellent CER Writer to meet the Clinical Evaluation Requirements

By |March 28th, 2023|Categories: Clinical Evaluation Reports - CER|Tags: |

The European Union Medical Device Regulation (EU MDR) has set higher standards for medical device clinical evaluation ERs) standards. With stricter regulations and guidelines, clinical evaluation report writing requires expertise, experience, and knowledge of the [...]

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IVDR: State-of-the-Art for In Vitro Diagnostic Medical Devices

By |March 21st, 2023|Categories: IVDR, Latest Publications|

With the updates to the European Medical Device and In Vitro Diagnostic Device Regulations (MDR 2017/745 and IVDR 2017/746, respectively), the requirements for clinical evidence were increased by the regulatory authorities. 1 Part of [...]

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Your Medical Device Got CE Marked – Now What?

By |February 28th, 2023|Categories: CE Marking, EU MDR, PMS PMCF, Post Market Surveillance|

Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]

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EU In Vitro Diagnostic Regulation (IVDR): Frequently Asked Questions

By |February 21st, 2023|Categories: IVDR, Latest Publications|Tags: |

The regulatory landscape in Europe is changing. In 2021, the new medical device regulation was implemented; in 2022, it was time for the in vitro diagnostic regulation. While the medical device regulation did not [...]

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