Dr. Krutika G.
Here you can find more info:https://www.krutikagohil.com/ I am an award-winning professional digital health innovator. With my well-founded s...
Professor Mark Flynn is the Executive Director of Global Impact Cluster for Better Health Healthcare and Treatment at the University of Newcast...
Dr. Precious O.
I am experienced in
Dr. Alpa B.
I am Dr. Alpa Ben, a BDS graduate from India. I have been working with healthcare service industry from past 8 years and have experience in var...
My expertise is development of clinical evaluation reports (CERs). This includes experience with literature searches, post-market surveillance,...
Dr. Srishti N.
"Research isn't complete until it has been communicated." A personal motto that has driven my passion for effective scientific c...
A clinical research scientific writer with clinical medical, CSR. and regulatory CER expertise in MEDDEV 2.7/1 rev4 documentation, EU MDR and F...
Dr. Harsh V.
A competent pharma professional with experience in Scientific writing, Regulatory competitive intelligence, DRA, F&D, MSAT and QA. Experie...
MDR and MDD Gap assessments and Remediation. Risk documents creation and all remediation process knowledge to get the CE mark for the product t...
• Scientific Writer with experience in end-to-end handling of Clinical Evaluation Reports (CERs, both MDD and MDR compliance). • Authored scien...
We are a team of experienced regulatory compliance expertise for Medical Devices and In-Vitro diagnostic devices across all risk classes. We ha...
Lakshman Prakash B.
Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...
Registered healthcare professional with 16 years of clinical experience in academic hospitals and clinical research. Trained in Clinical Evalua...
Vision-driven executive with over 25 years of demonstrated leadership in the pharmaceuticals industry. Proven track record of driving bold init...
An experienced professional with 20 years of industrial experience in MedTech, biopharmaceutical companies and semi-governmental organizations;...
Medical writing, Regulatory Writing, CER writing, Scientific consulting, Design, Biostatistics
EDUCATION: - Master in Science, Technology and Health - Sorbonne Université - France - Clinical Research Associate Certificate EXPERIENC...
Preparation of CER,PER, SSCP, PSURs, PMS Performing Literature search in Literature databases Hands on experience on Literature referencing to...
▪ Writing, reviewing quality and ensuring timely delivery of CEP/CER, PMSP/PMSR/PSUR to the client according to EU-MDR/MDD regulations and rela...
Masters in Biomedical Sciences, biotech, pharma experience. ICH CORE AMA MEDDEV FDA. Scientific writing/editing, research regulatory CME
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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 Clinical Evaluation Report Consultant
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
- Clinical Research
- EU Medical Device Regulations (MDR)
- Post-Market Surveillance
- Post-Market Clinical Followup
- Medical Writing
- Regulatory Writing
- Medical Affairs
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