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Dr. Sophie Laurenson
Healthcare and Technology Innovator and Entrepreneur
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$100.00/hr
Ph.D.
Switzerland
Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...
$100.00/hr
Dr. Catarina Carrão
Looking for quality Scientific & Medical writing? Look no further! Expert: Cardiology, Neurology, Oncology, Molecula...
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$100.00/hr
PhD
Austria
I did a PhD in Biochemistry and worked in biomedical research for the past 15 years. I have extensive experience in clinical research, scientif...
$100.00/hr
Dr. Ana Luiza Cassin Duz
Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
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$50.00/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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Dr. Aafaque Khan
Multi-disciplinary researcher |Medical Writer | Bioinformatics data analysis |Proteomics| Literature review | CER
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$70.00/hr
Ph.D
Canada
I am a multi-disciplinary researcher with more than 20 research publications in peer-reviewed journals and over 10 years of experience in resea...
$70.00/hr
Dr. Aali Khan
Ph.D. Bioinformatics
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$50.00/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.
$50.00/hr
Dr. Raeesa Gupte
Freelance CER Writer | Science and Medical Communications Specialist | Neurospsychiatry Expert | Creative Writer
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$75.00/hr
PhD
United States
I am a freelance science and medical writer catering to a diverse audience of scientists, healthcare professionals, pharmaceutical and medical ...
$75.00/hr
Dr. Tiago Veloso
An enriching journey from Academia to industry, from Biology to Infectious Diseases and further to Heart Valve diseases
PhD
Portugal
BSc in Biology and a PhD in Life Sciences - Microbiology and Infection. I have > 10 years of experience of research in Infectious Dise...
Girish Hirpara
Freelance Medical Writer / Expert in Medical Device with 13 Years of Experience in Clinical Research (MDR Expert)
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$50.00/hr
B.Pharmacy
India
An accomplished, versatile, results-oriented clinical research professional with over 13 years of experience in the Pharmaceuticals & M...
$50.00/hr
Adam Freeman
exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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$200.00/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...
$200.00/hr
Dr. Mary Ritchey
Experienced real-world researcher, generating evidence from clinical data for medical devices and pharmaceuticals.
PhD, Epidemiology
United States
Mary Beth Ritchey, PhD, FISPE has spent more than 15 years in government, industry, consulting, and academia in better understanding medical pr...
Dr. Mark Flynn
Experienced Medtech Commercial and Clinical Strategist
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$150.00/hr
MBA
Australia
Professor Mark Flynn is the Executive Director of Global Impact Cluster for Better Health Healthcare and Treatment at the University of Newcast...
$150.00/hr
Dr. Grace Chia
Experienced CER Writer for medical device companies
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$50.00/hr
Doctor of Philosophy (PhD) in Molecular Medicine
Malaysia
1. Preparation of Clinical Evaluation Reports (CERs) in accordance with Medical Device Regulation (MDR) and 93/42/EEC Medical Device Directive ...
$50.00/hr
Dr. Alex Langford-Smith
Former academic, medical devices regulatory affairs consultant, specialising in clinical and performance evaluation.
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...
Dr. DR. SENTHILKUMAR S
Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manuscript...
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$50.00/hr
Ph.D
India
Scientific Writer with 9+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations ...
$50.00/hr
Janet Kamana
Pharmacist and medical writer with over 11 years experience
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$50.00/hr
Professional Diploma in Medical Writing
Kenya
I am a pharmacist and a professional medical writer with over 11 years experience in various medical/pharmaceutical sectors including: researc...
$50.00/hr
Dr. Sergio Pérez, PhD
MDR Consultant / CER writer
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$55.00/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 ...
$55.00/hr
Madhu Srinivas Murthy
Experienced CER writer
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$60.00/hr
MBA
India
Authored medical device registration submissions (CERs) to international regulatory bodies (EU NBs) while ensuring regulatory compliance across...
$60.00/hr
Arjun Lakshmana Balaji
Physician | Clinical & Medical Affairs | CER | Scientific Writing | Pharma labeling | Strategy | HealthTech | Resear...
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$30.00/hr
Masters of Public Health (Epidemiology, Clinical Infectious Diseases and Global Health Majors)
India
I have a blend of experience in clinical medicine, pharmaceutical industry and medical device industry. As a medical doctor, I work on infectio...
$30.00/hr
Nida Ali
Experienced MDD and MDR certified CER/Technical File Writer with 5+ years of experience with multinational industries
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$50.00/hr
Bsc in Biomedical Engineering
Pakistan
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...
$50.00/hr
Giovanni Brusaferri
Freelance Statistician & Data Analyst | Expert in R | Expert in Orthopaedic Clinical Research
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$60.00/hr
Diploma of Advanced Studies (DAS-ETH) in Applied Statistics
Switzerland
Professional in the MedTech industry with Engineering and Statistics degrees. Seasoned in clinical research, in risk management within product ...
$60.00/hr
Dr. Jeremy Valluy
Freelance scientific consultant with 9+ years of experience in biotechnology and clinical research.
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$50.00/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...
$50.00/hr
Bharti Sharma
Freelance medical writer, COVID-19 virologist, Coronavirus expert, CER writer, MDR Consultant, Scientist, clinical trial
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$90.00/hr
Master of Public Health (M.P.H.), Introduction to Systematic Review and Meta-Analysis
India
A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...
$90.00/hr
Dr. Selina Meehleib
Experienced medical writer
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$70.00/hr
Doctorate of Medicine (MD)
United States
Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports ...
$70.00/hr
Dr. Mrudul Vekaria
Experienced medical writer/ MDR consultant
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$25.00/hr
Master of pharmacy
India
I am medical writer with more than 5 years of experience in writing regulatory and clinical research document. My expertise is development of c...
$25.00/hr
Dr. Waqar Latif Butt
Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
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$75.00/hr
PhD
Pakistan
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
$75.00/hr
Consult top medical device CER writers for help with clinical evaluation and EU MDR compliance. Post your project securely and get quotes for free. Kolabtree is the world's largest platform for hiring trusted freelance scientists and consultants on demand.
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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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