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Hire a Clinical Evaluation Report (CER) Expert

Ph.D.
Switzerland
USD100.0 per hour
Healthcare and Technology Innovator and Entrepreneur

Ph.D. level scientist with more than 17 years of experience in both academia and industry. Experience in multinational corporations, managing d...

Masters program about drug development
Spain
USD55.0 per hour
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 ...

PhD
United States
USD75.0 per hour
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 ...

Bachelor of Engineering on Genetics and Bioengineering Full Scholarship
Turkey
USD60.0 per hour
Clinical Evaluation Report (& PSUR, PMS, PMCF documentation) Writer | Expert in MDR

Medical writer with 5+ years of experience in clinical evalaution report, post-market surveillance plan and reports, PMCF and PSUR documentatio...

PhD
France
USD50.0 per hour
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...

Master of Public Health (M.P.H.), Introduction to Systematic Review and Meta-Analysis
India
USD90.0 per hour
Freelance CER writer, MDR Consultant, Scientist, medical writer , 21 years experience in clinical research, manuscripts.

A top rated writer & editor with emphasis on medical writing, scientific journal manuscripts, public health, environmental science and ...

Master of pharmacy
India
USD25.0 per hour
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...

B.Pharmacy
India
USD30.0 per hour
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 12 years of experience in the Pharmaceuticals & M...

Medical and Scientific Writing
United States
USD95.0 per hour
Senior Medical Writer at Medtronic

Having over 20-years’ experience working in nursing and public health research, I turned my focus to medical writing almost a decade ago. I ha...

Biomedical Engineering
India
USD10.0 per hour
https://www.linkedin.com/in/kalidoss-p-09353a65

Work experience in Medical device regulatory, cybersecurity of the medical device, clinical evaluation report analysis, risk benefit analysis.

MBA
India
USD40.0 per hour
Experienced CER writer

Authored medical device registration submissions (CERs) to international regulatory bodies (EU NBs) while ensuring regulatory compliance across...

MSc. Regulatory Affairs
United States
USD60.0 per hour
Medical Device CER & Regulatory Writer

A motivated medical writer, with 2+ years experience writing Clinical Evaluation Reports for medical devices in accordance with MEDDEV 2.7.1 Re...

B.E. Mechanical engineering
India
USD10.0 per hour
Expert in EU MDR and EU MDD Remediation and Gap assessments.

MDR and MDD Gap assessments and Remediation. Risk documents creation and all remediation process knowledge to get the CE mark for the product t...

PhD
United States
USD75.0 per hour
Medical writer with 10+ years of experience in medical research, medical affairs, and medical communications

Areas of expertise include oncology, dermatology, wound management and medical devices. Objective To use my extensive medical communication e...

PhD in Biochemistry
Australia
USD100.0 per hour
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...

Master of Science
United States
USD85.0 per hour
Experienced CER Writer

My expertise is development of clinical evaluation reports (CERs). This includes experience with literature searches, post-market surveillance,...

Masters degree in Biomedical Science
United States
USD110.0 per hour
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. ...

M.Sc Biochemistry
India
USD100.0 per hour
experience in Lifesciences in QA, QMS, Regulatory, EU-IVDR, medical device documentation writing clinical trial reports

Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...

Masters
United States
USD75.0 per hour
Biomedical writer experienced in research regulatory evidence-based writing/editing. AMWA member. 5+ years,

Masters in Biomedical Sciences, biotech, pharma experience. ICH CORE AMA MEDDEV FDA. Scientific writing/editing, research regulatory CME

Bachelors of Science in Biochemistry
Switzerland
USD500.0 per hour
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...

MS in Regulatory affairs
Canada
USD40.0 per hour
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...

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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 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

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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