Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...management, innovation management and science / medical writing (blog posts, medical writing, academic publications
I did a PhD in Biochemistry and worked in biomedical research for the past 15 years. I have extensive experience in clinical research, scientif...Stage Researcher in the Cardiovascular Center of the Charité (Berlin, Germany) resulted in two publicationsThis research work resulted in three publications, one as a co- first author.My most recent publication from this group was just approved for publishing in January 2019.In my profile, you can find links to all my publications, and also to the video of one of the Science
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...gt; Feasibility survey reports, disease demographics > Standalone QC and review of documents Publicationwriting services include: > Publication planning > Primary and secondary manuscript writing
A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...A strong background in viorology, medical microbiology and public health qualifies me to work on COVIDtop rated writer & editor with emphasis on medical writing, scientific journal manuscripts, public
I am a multi-disciplinary researcher with more than 20 research publications in peer-reviewed journals and over 10 years of experience in resea...I am a multi-disciplinary researcher with more than 20 research publications in peer-reviewed journals
I am a research scientist with 9+ years of experience designing, conducting and communicating research in biotechnology and medicine. I work as..., from experimental design to clinical evaluation reports, white papers or peer-reviewed scientific publicationsscientific research and communication, or a complete all-inclusive package, from study design to scientific publication
Professor Mark Flynn is the Executive Director of Global Impact Cluster for Better Health Healthcare and Treatment at the University of Newcast...He is the author of 14 worldwide patent families and over 50 publications on medical device technology
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A clinical evaluation report (CER) is a document required by all medical device companies that need to place a product in the EU market. It is submitted to a Notified Body (under the EU MDR) for CE Mark certification, which is required to sell or distribute medical devices in Europe. CERs are required for all medical device classifications in Europe and every medical device needs a dedicated CER.
A CER provides a detailed analysis of the safety and efficacy of a medical device, including data related to clinical trials, literature reviews, protocols and risk assessment. The document should contain the clinical evidence that supports proof of conformity to the Essential Requirements (ERs) in MEDDEV 2.7/1 Rev. 4 Annex 1 (Safety and Performance Requirements in the MDR). The document should also describe the physical and technical aspects of the device, the intended applications, and accurate references wherever applicable.
Preparing a CER can take several months and is a time-consuming and painstaking task. The clinical data included should be accurate and verified, and the product and its usage should be explained clearly as it affects the classification of the device. Medical device companies often require the help of a qualified freelance CER writer to help them prepare the document.
Data contained in the CER needs to be regularly updated even post-CE Marking. The details contained in the CER guides PMS (Post-Market Surveillance) and PMCF (Post-Market Clinical Followup) activities. The CER is not a static document. It is recommended that medical device manufacturers develop a robust process and strategy incorporating good practices to help them retain market market access in the EU, avoid any product recalls, and streamline their time and resources used to maintain the document.
Medical device companies are working hard to meet the guidelines laid down in the EU Medical Device Regulations (MDR). However, not all businesses can afford to have in-house staff dedicated to the upkeep of a CER. Working with an external team including CER strategy advisors and freelance medical writers can help them access the skills needed to put together the process and accelerate the regulatory approval process. CER authors are expected to have experience with regulatory affairs and medical device products, clinical data analysis, literature searches and technical writing.
Kolabtree’s global pool of experts include specialists who can help you take your medical device to market easily. It’s quick and easy to consult experts specialized in:
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