Profile Summary
Divya G.
NubGenix mainly focuses to support start up and mid-size medical device, combination products and pharmaceutical organizations. We provide supp...
Tarun S.
Medical device professional with strong background in single use disposables, reusable medical devices(Class I, Class II and Class III) . Broad...
Mike K.
Mr. Khalil’s professional career spans over thirty (30) years of executive and entrepreneurial leadership in pharmaceutical, medical devices, n...
Vaibh K.
Medical device risk assessment
Jose A.
Behind every successful medical device registration, there is a team of experts working hard to ensure it meets regulatory requirements. As a Q...
Arjun L.
I have a blend of experience in clinical medicine, pharmaceutical industry and medical device industry....As a medical doctor, I work on infectious diseases, pulmonary and critical care and public health....
Alekhya A.
Iam having 5 years experience in Research Writing and also keenly interested to work in Clinical Evaluation Reports, PSU , SEO, SOP , Medical D...
Neethu A.
Medical Device Regulatory Specialist with years of experience and a deep understanding of European and FDA medical device regulations. Investig...
Anupam M.
Experience summary: Author and review regulatory periodic safety reports (Periodic Benefit-Risk Evaluation Reports Developmental Safety Updat...
Rukmani S.
I am a biomedical research scientist and a science communicator based in Ireland with over 8 years experience writing/editing manuscripts, prep...
Caique M.
I am a freelance science and medicine writer, my focus is on implantable medical devices related to the areas of orthopedics. I specialized in ...
Kalidoss P.
Work experience in Medical device regulatory, cybersecurity of the medical device, clinical evaluation report analysis, risk benefit analysis.
Clifford T.
Medical technology and medical education marketing consultant and PR specialist, specializing in the cardiovascular field. Also, published jour...
Mohamed A.
I have an MBBCh degree from Assiut University and currently work as a medical intern at Assiut university hospital. I participated in multiple ...
Hayyan P.
I am a third-year MBBS student with a passion for medical writing and research. I specialize in creating high-quality health content, literatur...
Krishnakant S.
Regulatory Affairs and Toxicology Expertise: 1. Proficient in toxicological hazard assessment and human risk evaluation for product safety acro...
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Laura F.
Results-driven, hands on commercial trainer, revenue enablement leader with upstream (market research) and downstream (marcomm) marketing and b...
Dr. Muneeba A.
Need someone who can explain complex medical topics clearly and also write wellness content that actually connects with people? I do bot.... 👩⚕️ With a background in public health and pharmacy, I’ve written technical documents like...
Kristen D.
Innovative executive in clinical operations and regulatory affairs with successful experience in start-ups, hospital & CROs, private equity...
Dr. Raminder S.
Friendly and highly qualified Senior Scientist with 15+ years of international experience in molecular biology, genetics, tissue engineering, a...
Majid T.
I have several years of experience as a scientific editor and peer reviewer for a wide range of high-impact journals and international conferen...
Dr. Ross D.
Experienced medical writer and evidence consultant supporting biotech, pharma, and medtech clients across HTA submissions, systematic literatur...
Woodrow S.
I am a Certified Quality Engineer and ISO 13485-trained Lead Auditor with a background in biomedical engineering and hands-on experience leadin...
Deepak D.
Highly motivated Regulatory Affairs professional with strong expertise in U.S. FDA 510(k) submissions, Indian import licensing (CDSCO), ISO 134...
Namrata Priyadarshini H.
PhD in Nanotechnology with 3+ years of research and publication experience in therapeutics and catalysis. Skilled in manuscript preparation, li...
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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Hiring for clinical evaluation report services$450.00
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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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