The writing of medical and scientific documents, for example study documents or publications is an important part of research and scientific communication. All our medical writers have profound expertise in the area of diabetes and associated themes.
Besides publishing results from research conducted in our institute, we also offer medical writing for external research. One of our further core competences is the support in clinical evaluation reports for medical devices.
Preparation of a manuscript is done according to a preset concept. We search for literature, prepare the text, the graphs and tables and discuss the depicted results according to the current state of knowledge. Doing so, we adhere to good publication practise, the recommendations of the International Committee of Medical Journal Editors and the specific requirements of the journal. After critical review and approval by all authors, we take care of the submission of the article to the journal, the following correspondence and if applicable the necessary revisions after the peer-review-process. Besides original papers presenting study results, we prepare review articles, commentaries or other types of articles as well. We can also support you in publication of study results that were not gained in our institute.
Examples of journals in which we have already published
English language journals:
German language journals:
In order to receive the CE mark, the Medical Device Regulation (MDR) requires the planning, conduction and documentation of a clinical evaluation. This is necessary to prove the fulfillment of the essential requirements regarding safety and performance (GSPRs) of a medical device as well as preparation of a benefit-risk profile.
The data, which is gained during a clinical evaluation, in addition to literature is the groundwork for that. The results of a clinical evaluation will be compiled in a report, the so called clinical evaluation report. The guideline MEDDEV 2.7/1 rev. 4 is considered the gold standard in points of content and structure of a clinical evaluation. We support our customers in the initial clinical evaluation of their medical device, we help to extend the CE mark from existing medical devices (according to MDCG 2020-6) and support the clinical evaluation of medical device software (MDSW) (according to MDCG 2020-1).
Based on the technical documents and all available clinical data, we prepare all documents that are necessary for clinical evaluation:
We conduct the necessary literature searches and perform the analysis and assessment of the data. By doing this, our medical writers fulfil the requirements of MDR and MEDDEV 2.7/1 rev. 4.
To improve the reader-friendliness of our website, we use the generic masculine. In the context of equal treatment, we would like to point out that the content of our website is aimed at all genders and does not contain any valuation.
