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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...

PhD
Austria
USD100.0 per hour
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...

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 ...

B.Pharmacy
India
USD50.0 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 13 years of experience in the Pharmaceuticals & M...

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...

PhD in Medical Engineering
United Kingdom
USD125.0 per hour
| 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...

PhD
Portugal
USD0.0 per hour
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...

PhD, Epidemiology
United States
USD0.0 per hour
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...

Doctorate of Medicine (MD)
United States
USD70.0 per hour
Experienced medical writer

Medical Communications Consultant -Writing Clinical Evaluation Reports (CER) for medical device manufacturers -Preparation of clinical reports ...

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. ...

Ph.D
India
USD50.0 per hour
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 ...

Professional Diploma in Medical Writing
Kenya
USD50.0 per hour
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...

Bachelors of Science in Biochemistry
Switzerland
USD200.0 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...

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...

Master
Czech Republic
USD50.0 per hour
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...

Master degree in Science, Technology and Health
Vietnam
USD60.0 per hour
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...

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...

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...

MBA Quality Management
Brazil
USD50.0 per hour
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 ...

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,...

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...

PhD
Pakistan
USD75.0 per hour
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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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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