Top Freelance Clinical Evaluation Report Writers for Hire

Dr. Ahram Q.

Expert Life Science's Researcher, writer, and Consultant
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USD 50/hr
MPhil in Bioinformatics
Pakistan

My professional background is to technically write the Scientific content, assess the researcher in research work related to Bioinformatics and...

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USD 50/hr
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Dr. Kurtulus G.

Expert with 10+ Years of Experience in Medical, Scientific, Technical and Regulatory Writing
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USD 100/hr
Ph.D. Biotechnology
United States

I am a freelance medical, scientific, and technical writer with high-quality researches at Harvard Medical School proven by research papers pub...

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USD 100/hr
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Dr. Aafaque K.

Multi-omics |Medical Writer | Systematic Review and Meta Analysis |Proteomics| Literature review | Regulatory Compliance
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USD 70/hr
Ph.D
Canada

Welcome! I am Dr. Aafaque Khan, a seasoned scientist and dedicated researcher with a specialization in Biotechnology, Biochemistry, Genetic Eng...

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USD 70/hr
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Nida A.

Experienced MDR and FDA certified CER/Technical File Writer with 7+ years of experience with multinational industries
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USD 50/hr
Law (LLB Honours)
Pakistan

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...

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USD 50/hr
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Sundeep A.

Medical Device, IVD, QMS, CE Certificate, FDA 510(K), EU MDR, MDSAP, ISO 13485, SaMD, PMS, CER , PMCF, Risk Management
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USD 100/hr
Master of Technology - Quality Management
India

A seasoned professional with a decade of experience, I am a Leader and Speaker in the field of Quality Assurance & Regulatory Affairs, ...

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USD 100/hr
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Adam F.

exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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USD 200/hr
Bachelors of Science in Biochemistry
Switzerland

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...

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USD 200/hr
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Girish H.

Freelance Medical Writer / Regulatory Expert in Medical Device with 16+ Years of Experience (EUMDR, ISO 13485, FDA510K)
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USD 90/hr
B.Pharmacy
India

An accomplished, versatile, results-oriented clinical research professional with over 16 years of experience in the Pharmaceuticals & M...

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USD 90/hr
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Dr. Alex L.

Former academic, medical devices regulatory affairs consultant, specialising in clinical and performance evaluation.
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Doctor of Philosophy (PhD) Haematopoetic Stem Cell Gene Therapy
United Kingdom

Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...

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Dr. Sharma P.

Highly skilled QA and RA certified lead auditor with diverse industry experience in more than 56 markets with UK's N...
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USD 40/hr
M.Sc. (by Research) Biomedical Sciences
United Kingdom

Implementing ISO13485 and ISO9001 quality systems for various market requirements building compliant and conformant QMS and product regulatory ...

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USD 40/hr
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Dr. Aali K.

Ph.D. Bioinformatics
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USD 50/hr
Ph.D
India

I have expertise in Bioinformatics and other life sciences areas having more that 5 years of professional experience in various areas.

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USD 50/hr
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Dr. Ana Luiza C.

Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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USD 69/hr
MBA Quality Management
Brazil

I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...

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USD 69/hr
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Dr. Sergio P.

MDR Consultant / CER writer
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USD 55/hr
Masters program about drug development
Spain

I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...

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USD 55/hr
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Dr. SENTHILKUMAR S.

Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manusc...
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USD 75/hr
Ph.D
India

Scientific Writer with 10+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations...

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USD 75/hr
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Madhu S.

Quality and Regulatory Affairs professional | Expert in CE marking, EU MDR 2017, FDA submissions & lead auditor ISO1...
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USD 40/hr
Advanced PG Diploma in CR & Regulatory Affairs (APGDCR-RA)
India

Over 10 years’ experience in Quality and Regulatory Affairs, and technical submissions for a range of medical devices, including Orthopaedics, ...

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USD 40/hr
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Jean-Francois C.

Published Medical Scientist
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USD 50/hr
MD
United States

Published medical scientist: • Teaching classes on drug development and protocol writing at MCPHS (5 years) • Conducted several drug and device...

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USD 50/hr
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Anjali S.

Experience in Clinical Research & Development, Pharmacovigilance, QAQC, Medical and Medico and content writing
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USD 50/hr
Masters in Pharmacology( M. Pharm)
India

Performance-driven professional with total 2 decades of rich & extensive experience in Clinical Research & Development, Pharmac...

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USD 50/hr
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Dr. Jeremy V.

Freelance scientific consultant with 9+ years of experience in biotechnology and clinical research.
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USD 50/hr
PhD
France

I am a research scientist with 9+ years of experience designing, conducting and communicating research in biotechnology and medicine. I work as...

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USD 50/hr
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Rudra P.

Group of Clinical Research Professionals (Project Manager, Biostatisticians, CRAs, Medical Writers, SAS Prgmers)
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USD 70/hr
MS
India

We are a Contract Research Organization (CRO) that focuses on advanced project management, clinical operations, medical writing, statistical an...

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USD 70/hr
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Dr. Oyinkansola S.

Medical Doctor and Writer: Bridging Knowledge and Communication in Healthcare
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USD 40/hr
MPH
United Kingdom

Overview: As a dedicated Medical Doctor and accomplished Research Writer, I bring a unique blend of medical expertise and writing proficiency ...

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USD 40/hr
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Dr. Arinzechukwu U.

Freelance Scientific Writer and Consultant with over 6+ years in cancer research
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USD 100/hr
Molecular Haematology
United Kingdom

I have over 10+ years experience in medical/content/copywriting and proof-reading/editing as well as over 6+ years experience in cancer researc...

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USD 100/hr
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Dr. Murtaza Najabat A.

Medical Device Development | Healthcare Technology Specialist | Regulatory Affairs Specialist
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USD 80/hr
PhD in Materials Science
Pakistan

I am a biomedical engineer with over 20 years of experience in medical device development and healthcare technology. Apart from academia, I hav...

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USD 80/hr
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Dr. Pari J.

Medical Advisor/Clinical Research professional with PhD and 10+ years of global experience in Healthcare Industry
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USD 90/hr
PhD - Pharmacology
Australia

Digital Health an Medical/Scientific Affairs professional holding a Ph.D. degree in pharmacology with extensive academic and industry experienc...

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USD 90/hr
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Dr. Grace C.

Experienced CER Writer for medical device companies
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USD 50/hr
Doctor of Philosophy (PhD) in Molecular Medicine
Malaysia

1. Clinical Evaluation Report (CER) writer and authoring of Clinical Evaluation Plan (CEP) in accordance with Medical Device Regulation (MDR), ...

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USD 50/hr
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Dr. Kiran C.

Medical Writer with 5+ years experience in clinical research
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USD 65/hr
MPH
Canada

Experienced Medical Doctor and Clinical Research Associate with a demonstrated history of working in the medical practice industry. Skilled in ...

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USD 65/hr
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Dr. Waqar L.

Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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USD 75/hr
PhD
Pakistan

Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...

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USD 75/hr
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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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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: 

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