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MBA Quality Management
Brazil
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USD 50/hr
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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Ph.D.
Switzerland
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USD 100/hr
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
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PhD
Austria
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USD 150/hr
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
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PhD
United States
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USD 75/hr
I am a freelance science and medical writer who helps medical device and pharmaceutical companies create evidence-based content for physicians,...
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B.Pharmacy
India
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USD 90/hr
An accomplished, versatile, results-oriented clinical research professional with over 14 years of experience in the Pharmaceuticals & M...
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MS
India
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USD 70/hr
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
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Bsc in Biomedical Engineering
Pakistan
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An experienced clinical research and medical device Technical file writer who has certified on MEDDEV 2.7/1 Rev#4 documentation, EU MDR, ISO-10...
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Master of Public Health (M.P.H.), Fundamentals of Clinical Trials
India
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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
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Ph.D. Biotechnology
United States
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USD 125/hr
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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Ph.D
India
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USD 75/hr
Scientific Writer with 9+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations ...
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DMD, Dr, PhD, Specialist, Master Pharmacy
Serbia
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USD 120/hr
MDR/IVDR Focused on MDR/IVDR, CLINICAL RESEARCH TRIALS. CLINICAL EVALUATION and MQS IMPLEMENTATION. MDR/IVDR document preparation, including ev...
USD 120/hr
PhD - Pharmacology
Australia
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USD 90/hr
Medical/Scientific Affairs professional holding a Ph.D. degree in pharmacology with extensive academic and industry experience across various t...
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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...
MPH
Canada
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USD 65/hr
Experienced Medical Doctor and Clinical Research Associate with a demonstrated history of working in the medical practice industry. Skilled in ...
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Doctor of Philosophy (PhD) in Molecular Medicine
Malaysia
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USD 50/hr
1. Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive ...
USD 50/hr
PhD
Pakistan
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USD 75/hr
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
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Ph.D
India
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USD 50/hr
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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Ph.D
Canada
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USD 70/hr
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
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Master of Technology - Quality Management
India
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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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Masters program about drug development
Spain
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USD 55/hr
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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MD
United States
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Published medical scientist: • Teaching classes on drug development and protocol writing at MCPHS (5 years) • Conducted several drug and device...
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Bachelors of Science in Biochemistry
Switzerland
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USD 200/hr
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...
USD 200/hr
PhD
France
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USD 50/hr
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
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M.Pharm
India
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USD 50/hr
Pharmacovigilance-7 years and CER/PMS writing
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MBA
Australia
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USD 150/hr
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
USD 150/hr
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 scientists and consultants.
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CER required for pain relief patch$3000.00
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CE Mark for Class 1 medical device (MDD/MHRA) (rate per hour)$100.00
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Help with CER and EU MDR for a Class IIb/III medical device (rate per hour)$50.00
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Find freelance Clinical Evaluation Report (CER) experts by country
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 CER writer
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
EU Medical Device Regulations (MDR)
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