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Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...
Looking for quality Scientific & Medical writing? Look no further! Expert: Cardiology, Neurology, Oncology, Molecula...
I did a PhD in Biochemistry and worked in biomedical research for the past 15 years. I have extensive experience in clinical research, scientif...
MDR Consultant / CER writer
I have more than 6 years experience (research and pharmaceutical industry) with a long track of success. My years as a researcher provided me ...
Freelance CER Writer | Science and Medical Communications Specialist | Neurospsychiatry Expert | Creative Writer
I am a freelance science and medical writer catering to a diverse audience of scientists, healthcare professionals, pharmaceutical and medical ...
Freelance Medical Writer / Expert in Medical Device with 13 Years of Experience in Clinical Research (MDR Expert)
An accomplished, versatile, results-oriented clinical research professional with over 13 years of experience in the Pharmaceuticals & M...
Freelance scientific consultant with 9+ years of experience in biotechnology and clinical research.
I am a research scientist with 9+ years of experience designing, conducting and communicating research in biotechnology and medicine. I work as...
| Medical Devices | Global Regulations | Technical Files | Risk Management | e-QMS | Clinical Evaluation | PMS |
Dr Shah has a PhD in Medical Engineering (2018, UK) and is a Qualified Pharmacist. His standout Credentials: # Excellent regulatory writing ...
Master of Public Health (M.P.H.), Introduction to Systematic Review and Meta-Analysis
India
USD90.0 per hour
Freelance medical writer, COVID-19 virologist, Coronavirus expert, CER writer, MDR Consultant, Scientist, clinical trial
A strong background in viorology, medical microbiology and public health qualifies me to work on COVID-19 projects (factsheets, COVID-19 at hom...
An enriching journey from Academia to industry, from Biology to Infectious Diseases and further to Heart Valve diseases
BSc in Biology and a PhD in Life Sciences - Microbiology and Infection. I have > 10 years of experience of research in Infectious Dise...
Experienced real-world researcher, generating evidence from clinical data for medical devices and pharmaceuticals.
Mary Beth Ritchey, PhD, FISPE has spent more than 15 years in government, industry, consulting, and academia in better understanding medical pr...
Experienced medical writer
Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports ...
CER Medical Writer/Associate Project Manager
A clinical research scientific writer with medical and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and FDA compliance. ...
Helping Medical Device Companies as an SME in developing CEP, CER, PMS Plan, PSUR, PMCF Plan & Report and Manuscript...
Scientific Writer with 9+ years of experience with a demonstrated history of working in the Medical Device domain, SME in Clinical Evaluations ...
Pharmacist and medical writer with over 11 years experience
I am a pharmacist and a professional medical writer with over 11 years experience in various medical/pharmaceutical sectors including: researc...
exFDA Investigator / expert in Medical Device & Combination Product design, manufacturing, and compliance
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...
Experienced CER writer
Authored medical device registration submissions (CERs) to international regulatory bodies (EU NBs) while ensuring regulatory compliance across...
Experienced Clinical Evaluation and Post Market Surveillance freelance writer
CER for class I, IIa and IIb medical devices in compliance with MDD requirements Post Market Surveillance Plans and Reports (MDD) Literature se...
Medical Writer - Medical Device Consultant - Clinical Evaluation Report - MDD/ MDR/ MEDDEV
EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...
Masters of Public Health (Epidemiology, Clinical Infectious Diseases and Global Health Majors)
India
USD30.0 per hour
Physician | Clinical & Medical Affairs | CER | Scientific Writing | Pharma labeling | Strategy | HealthTech | Resear...
I have a blend of experience in clinical medicine, pharmaceutical industry and medical device industry. As a medical doctor, I work on infectio...
Regulatory affairs, Quality assurance and a medical writer with 13+ experience in medical device and pharma industry
Accomplished pharmaceutical and medical device regulatory and quality professional with over 12 years experience in regulatory compliance, prod...
Experienced medical writer/ MDR consultant
I am medical writer with more than 5 years of experience in writing regulatory and clinical research document. My expertise is development of c...
Freelance Medical writer, Clinical specialist and Regulatory affairs of Medical Devices, Ph.D. Biological Sciences
I have over 8 years of experience in Clinical Research, Regulatory Affairs and Quality Assurance of implantable and electro medical devices in ...
Experienced CER Writer
My expertise is development of clinical evaluation reports (CERs). This includes experience with literature searches, post-market surveillance,...
English Chinese Medical Writer, Medical Translator, CER Writer, Medical Interpreter
Is your medical and health business looking for help with English Chinese medical communications? When working with me, you will receive the de...
Auditing, Consulting, Training and Operations Management for International Standards i.e. ISO, BSCI, DIN, MDD, MDR, PPE
Ten + years of hands-on technical working experience in the manufacturing environment covering Metal, Textiles, Food, Auto parts, Chemical proc...
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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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