プロファイルの概要
Dr. Kurtulus G.
I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...
Dr. Sarah L.
I help MedTech, Biotech, and Pharma startups bridge the gap between innovation and market reality across three complementary domains. 1. Start...
I am Dr. Alpa Ben, a BDS graduate from India. I have been working with healthcare service industry from past 8 years and have experience in var...
"Research isn't complete until it has been communicated." A personal motto that has driven my passion for effective scientific c...
• Scientific Writer with experience in end-to-end handling of Clinical Evaluation Reports (CERs, both MDD and MDR compliance). • Authored scien...
▪ Writing, reviewing quality and ensuring timely delivery of CEP/CER, PMSP/PMSR/PSUR to the client according to EU-MDR/MDD regulations and rela...
Dr. Aimilia M.
Experienced Scientific Editor holding a PhD in Chemistry, with 10+ years of experience in research and 5+ years of experience in editing. Area...
Dr. Anurag G.
In high-stakes clinical and regulatory environments, the quality of your data is irrelevant if your documentation fails to satisfy a Notified B...
Consult top freelance clinical evaluation report writers with expertise in clinical evaluation documents writing, clinical study reports, and more. Kolabtree is the world's largest platform for hiring trusted freelance clinical evaluation consultants.
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Looking for clinical evaluation consultants$550.00
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Need to outsource clinical evaluation report writing services$500.00
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CER medical writer required$550.00
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What Is a Clinical Evaluation Report (CER)?
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.
What Does a Clinical Evaluation Report Contain?
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.
How Long Does It Take To Write a CER?
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.
How to Write a CER
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.
How to Hire a Freelance Clinical Evaluation Report Consultant
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:
- Clinical Evaluation Report (CER) Writing
- Biostatistics
- Clinical Research
- EU Medical Device Regulations (MDR)
- Post-Market Surveillance
- Post-Market Clinical Followup
- Medical Writing
- Regulatory Writing
- Medical Affairs
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