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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. SENTHILKUMAR S.
Scientific Writer with 10+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations...
An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR 2017/74...
Muhammad A.
Greetings, Welcome to our hub of professional writing and research, where a dedicated team with over five years of solid experience provides ...
Dr. Ahram Q.
My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...
An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & M...
Dr. Alex L.
Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...
Dr. Arinzechukwu U.
I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...
Dr. Grace C.
1. Clinical Evaluation Report (CER) writer and authoring of Clinical Evaluation Plan (CEP) in accordance with Medical Device Regulation (MDR), ...
Dr. Ana Luiza C.
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
• A competent Professional Medical Writer with over 7+ years' of experience in Regulatory Compliance, Quality Systems, Clinical Research, ...
Sundeep A.
A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...
I performed inspections and premarket approvals for FDA for 7.5 years. I am now a Senior Consultant operating out of Switzerland. I operate a...
Dr. Jeremy V.
I am a research scientist with 9+ years of experience designing, conducting and communicating research in biotechnology and medicine. I work as...
Performance-driven professional with total 2 decades of rich & extensive experience in Clinical Research & Development, Pharmac...
We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...
Dr. Pari J.
Digital Health an Medical/Scientific Affairs professional holding a Ph.D. degree in pharmacology with extensive academic and industry experienc...
Dr. Kiran C.
Experienced Medical Doctor and Clinical Research Associate with a demonstrated history of working in the medical practice industry. Skilled in ...
Dr. Waqar L.
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
Dr. DURGA PRASAD G.
Pharmacovigilance-7 years and CER/PMS writing
Dr. Krutika G.
Here you can find more info:https://www.krutikagohil.com/ I am an award-winning professional digital health innovator. With my well-founded s...
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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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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